[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35691-35698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14476]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0517]


Notice of Withdrawal of Certain Unapproved Abbreviated New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing its intention to deem to be withdrawn any abbreviated new 
drug applications (ANDAs) that have been determined to be incomplete 
and as to which the ANDA applicant has not communicated with FDA since 
July 8, 1991. Each of these applications will be

[[Page 35692]]

deemed to have been withdrawn voluntarily by the applicant unless the 
applicant informs the Agency in writing that it intends to actively 
pursue approval of the application(s) (see DATES).

DATES: The applicant of an ANDA covered by this notice that intends to 
actively pursue approval of its application must submit a written 
notification to FDA by August 13, 2012.

ADDRESSES: Applicants should submit written notifications to the ANDA 
archival file to the Office of Generic Drugs, Center for Drug 
Evaluation and Research, Food and Drug Administration, Document Control 
Room, MPN7, 7620 Standish Pl., Rockville, MD 20855. A copy of written 
notifications should also be submitted to Thomas Hinchliffe, Center for 
Drug Evaluation and Research (HFD-617), Food and Drug Administration, 
7500 Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, FAX: 240-276-
8440, email: [email protected].

FOR FURTHER INFORMATION CONTACT: Thomas Hinchliffe, Center for Drug 
Evaluation and Research (HFD-617), Food and Drug Administration, 7500 
Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, 240-276-8433, FAX: 
240-276-9310, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has identified 364 ANDAs for which FDA has not received any 
communication from the ANDA applicant since July 8, 1991, or earlier 
(Inactive ANDAs). (See section IV of this document for the list of 
Inactive ANDAs). For purposes of this document, the term ``applicant'' 
includes any successor in interest. FDA's regulations provide that the 
Agency will consider withdrawn any application for which the applicant 
has not contacted the Agency about its intention regarding such 
application within 1 year after issuance of a complete response letter 
to the applicant (see 21 CFR 314.110(c)). The Inactive ANDAs, however, 
predate, and consequently are not subject to this regulation. 
Therefore, the Inactive ANDAs have not been deemed withdrawn although 
there has been no communication from the applicants since July 8, 1991, 
or earlier.

II. Withdrawal of Inactive ANDAs

    At this time, the Agency is announcing its intention to deem all 
Inactive ANDAs to have been voluntarily withdrawn by the respective 
applicants as of August 13, 2012, unless the applicant informs the 
Agency in writing by the date set forth under DATES in this document of 
its intent to actively pursue approval of the application. Therefore, 
in the absence of a written notice with respect to an Inactive ANDA by 
the date specified in this notice, the ANDA will be considered to have 
been withdrawn by the applicant. No further notice of the withdrawal of 
Inactive ANDAs will be provided. Withdrawal of an unapproved 
application is without prejudice to resubmission of that application 
(21 CFR 314.65). Because of the length of time that has passed since 
these applications were submitted, FDA strongly recommends that any 
applicant intending to actively pursue approval review the application 
carefully to determine whether it satisfies current ANDA requirements 
(21 CFR part 314).

III. Action by the Applicant

    If the applicant wishes to actively pursue approval of an Inactive 
ANDA and does not wish the application to be deemed by FDA to have been 
voluntarily withdrawn, the applicant must inform the Agency in writing 
within the time specified in this document. Written notice should be 
provided to Thomas Hinchliffe and the Office of Generic Drugs (see 
ADDRESSES).
    FDA also asks any applicant that agrees to consider its application 
to be voluntarily withdrawn to send a written notice to Thomas 
Hinchliffe and the Office of Generic Drugs (see ADDRESSES) to confirm 
that agreement. However, applicants of Inactive ANDAs covered by this 
notice who wish their applications to be withdrawn are not required to 
provide written notice to FDA.

IV. Details About Inactive ANDAs

    Information about the Inactive ANDAs is listed in this section of 
the document. To protect applicant confidentiality, this notice lists 
the application number and drug name for each Inactive ANDA and 
separately lists the name of the applicant as shown in the information 
on file with FDA, without linking identified applicants with specific 
applications or drug names. In some cases, the identified applicants 
may no longer exist as ongoing business entities. If an identified 
applicant is unsure which application(s) belong to it (if any), it may 
contact Thomas Hinchliffe (see FOR FURTHER INFORMATION CONTACT).

Alphabetical List of Abbreviated New Drug Application Applicants

1st Texas Pharmaceuticals, Inc., Subsidiary of Scherer Laboratories 
Inc.
Abraxis Pharmaceutical Products
AH Robins, Co.
Alpharma US Pharmaceuticals Division
Ambix Laboratories Division of Organics Corp America
Ankerfarm SpA
Ankerman SpA
Antibioticos SA
Arcum Pharmaceutical Corp.
Banner Pharmacaps, Inc.
Barr Laboratories, Inc.
Baxter Healthcare Corp.
Beecham Laboratories Division of Beecham Inc.
Beecham SA
Bel Mar Laboratories, Inc.
Biocraft Laboratories, Inc.
Biometric Testing, Inc.
Boots Laboratories, Inc., Division of Boots Pharmaceuticals Inc.
Bristol Laboratories, Inc., Division of Bristol Myers Co.
Bristol Myers Co. International Division
Bristol Myers Industrial Division
Bristol Myers Squibb
Camall Co., Inc.
Carlo Erba SpA
Century Pharmaceuticals, Inc.
Chemibiotic Ireland, Ltd.
Chromalloy Laboratories Division of Chromalloy Pharmaceuticals, Inc.
Clifford Chemical Corp.
CM Bundy Co.
Comatic Laboratories, Inc.
Credo Co.
Delco Chemical Co., Inc.
Dell Laboratories, Inc.
Dermasave Laboratories, Inc.
Dista Products Co. Division of Eli Lilly & Co.
DM Pharmaceuticals, Inc.
Dorasol Laboratories
Dunhall Pharmaceuticals, Inc.
ER Squibb and Sons Pharmaceutical Laboratories
Ersana, Inc., Subsidiary of ER Squibb and Sons
Everylife
Fallek Products Co., Inc.
Farmila Farmaceutica
Faton Pharmaceuticals, Inc.
Fermion Oy
Ferndale Laboratories, Inc.
Fisons Corp.
Forest Laboratories, Inc.
Forest Pharmaceuticals, Inc.
Forrest Laboratories, Inc.
G & W Co.
Glenwood Laboratories, Inc.
Global Pharmaceutical Corp.
Gruppo Lepetit SpA Subsidiary of Merrell Dow Pharmaceuticals, Inc.
Heather Drug Co., Inc.
Herald Pharmacal, Inc.
Hoffmann La Roche, Inc.
ICI Ltd.
Ingram Pharmaceutical Co.
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc.

[[Page 35693]]

ISF
Kasar Laboratories Division of Kasar Co.
Kasco EFCO Laboratories, Inc., Division of Byk Gulden, Inc.
KV Pharmaceutical, Co.
Lannett Co, Inc.
Lederle Laboratories Division of American Cyanamid Co.
Leiner Health Products, Inc.
Lemmon Co. Subsidiary of Tag Pharmaceutical, Inc.
Life Laboratories, Inc.
Linden Laboratories, Inc., Subsidiary of Chromalloy American Corp.
Luitpold Pharmaceuticals, Inc.
Marshall Pharmacal Corp.
MD Pharmaceutical, Inc.
Medev, Inc.
Mission Pharmacal Co.
M M Mast & Co.
Mutual Pharmaceutical Company, Inc.
Newtron Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corp.
Nylos Trading Co., Inc.
Panray Corp Subsidiary of Ormont Drug and Chemical Co., Inc.
Parke Davis Division of Warner Lambert Co.
Pasadena Research Laboratories, Inc.
Penick Corp.
Person and Covey, Inc.
Pfizer Co.
Pfizer, Inc.
Pharmaceutical Associates, Inc.
Pharmacia and Upjohn Co.
Pharmadyne Laboratories, Inc.
Pharmavite Pharmaceuticals
Phoenix Laboratories, Inc.
Polfa Pharmaceutical Works
Premo Pharmaceutical Laboratories, Inc.
Purepac Pharmaceutical Co.
Rachelle Laboratories Italia SpA
Reed and Carnrick Division of Block Drug Co., Inc.
Rexar Pharmacal
Richlyn Laboratories, Inc.
Robinson Laboratories, Inc.
Roussel Corp.
Rovers Pharmacal, Inc.
RP Scherer Corp.
Sandoz, Inc.
Scherer Laboratories, Inc.
Schering Corp. Subsidiary of Schering Plough Corp.
Smith Kline and French Laboratory Co. Subsidiary of SmithKline Beckman
Societa Italiana Prodotti Schering
Sperti Drug Products, Inc.
Stayner Corp.
Steri Med, Inc. Subsidiary of Ketchum Laboratories, Inc.
Tablicaps, Inc.
Tera Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Titan Pharmacal, Co.
Travenol Laboratories, Inc.
Valeant Pharmaceuticals International
Watson Laboratories, Inc.
Western Research Laboratories, Inc.
West-Ward Pharmaceutical Corp.
Wharton Laboratories, Inc., Division of US Ethicals
Whiteworth Towne Paulsen, Inc.
Wyeth Ayerst Laboratories
Zenith Laboratories, Inc.

  Table 1--Abbreviated New Drug Application (ANDA) Numbers With Product
                                  Names
------------------------------------------------------------------------
                     ANDA No.                           Product name
------------------------------------------------------------------------
60881.............................................  Tetracycline
                                                     hydrochloride.
60913.............................................  Dicloxacillin
                                                     sodium.
60919.............................................  Neomycin sulfate;
                                                     bacitracin.
60965.............................................  Neomycin sulfate;
                                                     polymyxin b
                                                     sulfates;
                                                     bacitracin.
61046.............................................  Penicillin g sodium.
61091.............................................  Phenethicillin
                                                     potassium.
61093.............................................  Penicillin g
                                                     potassium.
61097.............................................  Troleandomycin.
61099.............................................  Doxycycline hyclate.
61102.............................................  Oxytetracycline
                                                     calcium.
61114.............................................  Chlortetracycline
                                                     hydrochloride.
61116.............................................  Ampicillin
                                                     trihydrate.
61117.............................................  Phenethicillin
                                                     potassium.
61118.............................................  Cloxacillin sodium.
61119.............................................  Dicloxacillin
                                                     sodium.
61120.............................................  Tetracycline.
61121.............................................  Tetracycline
                                                     phosphate.
61142.............................................  Penicillin g
                                                     potassium.
61144.............................................  Amphotericin b.
61145.............................................  Penicillin g
                                                     potassium.
61152.............................................  Tetracycline
                                                     hydrochloride.
61170.............................................  Bacitracin.
61171.............................................  Bacitracin zinc.
61191.............................................  Tetracycline
                                                     hydrochloride.
61192.............................................  Tetracycline
                                                     hydrochloride.
61194.............................................  Paromomycin sulfate.
61197.............................................  Tetracycline
                                                     hydrochloride.
61382.............................................  Ampicillin
                                                     trihydrate.
61420.............................................  Tetracycline.
61422.............................................  Oxytetracycline
                                                     hydrochloride.
61423.............................................  Oxytetracycline.
61428.............................................  Chloramphenicol
                                                     palmitate.
61429.............................................  Tetracycline.
61430.............................................  Chloramphenicol.
61431.............................................  Chloramphenicol.
61432.............................................  Chloramphenicol
                                                     sodium succinate.
61433.............................................  Chloramphenicol
                                                     sodium succinate.
61440.............................................  Tetracycline
                                                     hydrochloride.
61442.............................................  Erythromycin
                                                     estolate.
61556.............................................  Tetracycline.
61564.............................................  Methacycline
                                                     hydrochloride.
61565.............................................  Paromomycin sulfate.
61570.............................................  Hetacillin.

[[Page 35694]]

 
61581.............................................  Tetracycline
                                                     hydrochloride.
61582.............................................  Tetracycline.
61597.............................................  Ampicillin
                                                     trihydrate.
61604.............................................  Ampicillin sodium.
61608.............................................  Tetracycline
                                                     hydrochloride.
61629.............................................  Penicillin g
                                                     benzathine.
61630.............................................  Streptomycin
                                                     sulfate.
61631.............................................  Dihydrostreptomycin
                                                     sulfate.
61749.............................................  Dicloxacillin
                                                     sodium.
61750.............................................  Ampicillin
                                                     trihydrate.
61751.............................................  Doxycycline hyclate.
61754.............................................  Griseofulvin.
61775.............................................  Tetracycline.
61777.............................................  Mitomycin.
61778.............................................  Erythromycin.
61779.............................................  Erythromycin
                                                     stearate.
61784.............................................  Tetracycline
                                                     hydrochloride.
61795.............................................  Oxacillin sodium.
61796.............................................  Oxacillin sodium.
61797.............................................  Methicillin sodium.
61804.............................................  Carbenicillin
                                                     indanyl sodium.
61824.............................................  Tetracycline.
61825.............................................  Tetracycline.
61843.............................................  Penicillin v
                                                     potassium.
61844.............................................  Ampicillin.
61845.............................................  Ampicillin
                                                     trihydrate.
61852.............................................  Tetracycline
                                                     phosphate complex.
61993.............................................  Cloxacillin sodium.
62016.............................................  Amoxicillin
                                                     trihydrate.
62019.............................................  Tetracycline
                                                     hydrochloride.
62020.............................................  Tetracycline
                                                     phosphate.
62344.............................................  Cloxacillin sodium.
80004.............................................  Propylthiouracil.
80088.............................................  Sulfadiazine.
80200.............................................  Succinylcholine
                                                     chloride.
80313.............................................  Methyltestosterone.
80350.............................................  Prednisone.
80351.............................................  Prednisolone.
80359.............................................  Prednisone.
80452.............................................  Hydrocortisone.
80456.............................................  Hydrocortisone.
80501.............................................  Diphenhydramine
                                                     hydrochloride.
80559.............................................  Cyanocobalamin.
80560.............................................  Pyridoxine
                                                     hydrochloride.
80561.............................................  Thiamine
                                                     hydrochloride.
80616.............................................  Cyanocobalamin.
80676.............................................  Testosterone
                                                     propionate.
80840.............................................  Propylthiouracil.
80943.............................................  Vitamin a palmitate.
80947.............................................  Aminosalicylate
                                                     sodium.
80956.............................................  Vitamin d.
80985.............................................  Vitamin a.
83002.............................................  Diethylstilbestrol.
83003.............................................  Diethylstilbestrol.
83004.............................................  Diethylstilbestrol.
83005.............................................  Diethylstilbestrol.
83006.............................................  Diethylstilbestrol.
83007.............................................  Diethylstilbestrol.
83114.............................................  Vitamin a palmitate.
83133.............................................  Folic acid.
83134.............................................  Vitamin a.
83197.............................................  Propoxyphene
                                                     hydrochloride.
83203.............................................  Niacin.
83208.............................................  Cortisone acetate.
83233.............................................  Hydrocortisone
                                                     acetate.
83243.............................................  Chlorpheniramine
                                                     maleate.
83258.............................................  Butabarbital sodium.
83259.............................................  Pentobarbital
                                                     sodium.
83268.............................................  Butabarbital sodium.
83269.............................................  Butabarbital sodium.
83293.............................................  Propoxyphene
                                                     hydrochloride.
83311.............................................  Vitamin a palmitate.

[[Page 35695]]

 
83321.............................................  Vitamin a palmitate.
83335.............................................  Prednisolone
                                                     acetate.
83343.............................................  Meprobamate.
83374.............................................  Estrogens,
                                                     esterified.
83394.............................................  Chlorpheniramine
                                                     maleate.
83421.............................................  Probenecid.
83439.............................................  Quinidine sulfate.
83444.............................................  Rauwolfia
                                                     serpentina.
83454.............................................  Lidocaine.
83494.............................................  Meprobamate.
83503.............................................  Negatol.
83537.............................................  Secobarbital sodium.
83553.............................................  Procainamide
                                                     hydrochloride.
83562.............................................  Prednisolone
                                                     acetate.
83578.............................................  Butabarbital sodium.
83674.............................................  Diphenhydramine
                                                     hydrochloride.
83675.............................................  Prednisolone.
83676.............................................  Prednisone.
83756.............................................  Piperazine citrate.
83772.............................................  Pyridoxine
                                                     hydrochloride.
83864.............................................  Secobarbital sodium.
83865.............................................  Promethazine
                                                     hydrochloride.
83867.............................................  Rauwolfia
                                                     serpentina.
83880.............................................  Propoxyphene
                                                     hydrochloride.
83912.............................................  Vitamin a palmitate.
83926.............................................  Ergotamine tartrate;
                                                     caffeine.
83929.............................................  Cortisone acetate.
83940.............................................  Diethylstilbestrol.
83958.............................................  Propylthiouracil.
83960.............................................  Prednisolone.
83974.............................................  Trihexyphenidyl
                                                     hydrochloride.
84008.............................................  Chlorpheniramine
                                                     maleate.
84009.............................................  Prednisone.
84016.............................................  Dextroamphetamine
                                                     hydrochloride.
84027.............................................  Promethazine
                                                     hydrochloride.
84073.............................................  Benzthiazide.
84080.............................................  Promethazine
                                                     hydrochloride.
84097.............................................  Dicyclomine
                                                     hydrochloride.
84237.............................................  Niacin.
84257.............................................  Dicyclomine
                                                     hydrochloride.
84262.............................................  Phenylbutazone.
84263.............................................  Dimenhydrinate.
84293.............................................  Dicyclomine
                                                     hydrochloride.
84298.............................................  Hydrochlorothiazide.
84311.............................................  Phenylbutazone.
84365.............................................  Dexamethasone sodium
                                                     phosphate.
84382.............................................  Meclizine
                                                     hydrochloride.
84410.............................................  Trichlormethiazide.
84428.............................................  Propantheline
                                                     bromide.
84459.............................................  Propylthiouracil.
84485.............................................  Phentermine
                                                     hydrochloride.
84552.............................................  Aminophylline.
84559.............................................  Theophylline.
84632.............................................  Aminophylline.
84670.............................................  Chlordiazepoxide.
84671.............................................  Chlordiazepoxide.
84672.............................................  Chlordiazepoxide.
84695.............................................  Phentermine
                                                     hydrochloride.
84736.............................................  Rescinnamine.
84846.............................................  Methocarbamol.
84856.............................................  Cortisone acetate.
84871.............................................  Prednisolone
                                                     acetate.
84906.............................................  Reserpine;
                                                     hydrochlorothiazide
                                                     .
84979.............................................  Hydrocortisone.
85033.............................................  Methocarbamol.
85115.............................................  Prednisone.
85170.............................................  Prednisolone.
85174.............................................  Cortisone acetate.
85185.............................................  Diethylpropion
                                                     hydrochloride.
85207.............................................  Reserpine.
85242.............................................  Chlordiazepoxide
                                                     hydrochloride.
85258.............................................  Chlordiazepoxide.

[[Page 35696]]

 
85259.............................................  Chlordiazepoxide.
85270.............................................  Methyltestosterone.
85280.............................................  Chlordiazepoxide
                                                     hydrochloride.
85281.............................................  Chlordiazepoxide
                                                     hydrochloride.
85308.............................................  Phenytoin sodium.
85325.............................................  Methylprednisolone.
85360.............................................  Chlordiazepoxide
                                                     hydrochloride.
85405.............................................  Perphenazine.
85412.............................................  Tripelennamine
                                                     hydrochloride.
85419.............................................  Quinidine sulfate.
85439.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
85442.............................................  Chlordiazepoxide
                                                     hydrochloride.
85489.............................................  Probenecid.
85516.............................................  Theophylline.
85576.............................................  Estradiol.
85590.............................................  Oxyphenbutazone.
85592.............................................  Brompheniramine
                                                     maleate.
85613.............................................  Phendimetrazine
                                                     tartrate.
85647.............................................  Amitriptyline
                                                     hydrochloride.
85649.............................................  Amitriptyline
                                                     hydrochloride.
85678.............................................  Amitriptyline
                                                     hydrochloride.
85680.............................................  Amitriptyline
                                                     hydrochloride.
85696.............................................  Isoniazid;
                                                     pyridoxine
                                                     hydrochloride.
85707.............................................  Isopropamide iodide.
85716.............................................  Hydralazine
                                                     hydrochloride.
85717.............................................  Hydralazine
                                                     hydrochloride.
85725.............................................  Phendimetrazine
                                                     tartrate.
85730.............................................  Cyanocobalamin.
85731.............................................  Phentermine
                                                     hydrochloride.
85760.............................................  Chlorothiazide.
85774.............................................  Methyltestosterone.
85776.............................................  Methyltestosterone.
85806.............................................  Reserpine;
                                                     hydralazine
                                                     hydrochloride;
                                                     hydrochlorotiazide.
85807.............................................  Meclizine
                                                     hydrochloride.
85808.............................................  Meclizine
                                                     hydrochloride.
85812.............................................  Propoxyphene
                                                     hydrochloride.
85901.............................................  Imipramine
                                                     hydrochloride.
85918.............................................  Ergotamine tartrate;
                                                     caffeine.
85942.............................................  Amitriptyline
                                                     hydrochloride.
85943.............................................  Triamcinolone
                                                     acetonide.
85946.............................................  Amitriptyline
                                                     hydrochloride.
85947.............................................  Amitriptyline
                                                     hydrochloride.
85948.............................................  Amitriptyline
                                                     hydrochloride.
85949.............................................  Amitriptyline
                                                     hydrochloride.
85950.............................................  Amitriptyline
                                                     hydrochloride.
85954.............................................  Methyltestosterone.
85955.............................................  Methyltestosterone.
85972.............................................  Acetaminophen;
                                                     salicylamide;
                                                     caffeine; codeine
                                                     phosphate.
86068.............................................  Triamcinolone
                                                     acetonide.
86111.............................................  Amodiaquine
                                                     hydrochloride.
86115.............................................  Bethanechol
                                                     chloride.
86125.............................................  Quinidine sulfate.
86128.............................................  Chlorpromazine.
86131.............................................  Acetazolamide.
86207.............................................  Hydrocortisone
                                                     acetate.
86211.............................................  Phendimetrazine
                                                     tartrate.
86253.............................................  Trihexyphenidyl
                                                     hydrochloride.
86254.............................................  Chlorothiazide.
86279.............................................  Hydrochlorothiazide.
86286.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
86288.............................................  Amitriptyline
                                                     hydrochloride.
86316.............................................  Orphenadrine
                                                     citrate.
86317.............................................  Diphenoxylate
                                                     hydrochloride;
                                                     atropine sulfate.
86318.............................................  Hydrochlorothiazide.
86319.............................................  Hydrochlorothiazide.
86320.............................................  Methocarbamol.
86321.............................................  Methocarbamol.
86322.............................................  Prednisone.
86324.............................................  Prednisone.
86326.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
86327.............................................  Trifluoperazine
                                                     hydrochloride.
86334.............................................  Hydrocortisone.

[[Page 35697]]

 
86343.............................................  Thioridazine
                                                     hydrochloride.
86345.............................................  Thioridazine
                                                     hydrochloride.
86354.............................................  Thioridazine
                                                     hydrochloride.
86377.............................................  Hydrochlorothiazide.
86400.............................................  Hydrocortisone
                                                     acetate.
86401.............................................  Hydrocortisone
                                                     acetate.
86404.............................................  Phendimetrazine
                                                     tartrate.
86407.............................................  Phendimetrazine
                                                     tartrate.
86411.............................................  Dimenhydrinate.
86412.............................................  Dicyclomine
                                                     hydrochloride.
86430.............................................  Phendimetrazine;adip
                                                     ic acid.
86431.............................................  Phendimetrazine.
86436.............................................  Homatropine
                                                     methylbromide.
86437.............................................  Homatropine
                                                     hydrobromide.
86438.............................................  Trifluoperazine
                                                     hydrochloride.
86443.............................................  Trifluoperazine
                                                     hydrochloride.
86447.............................................  Trifluoperazine
                                                     hydrochloride.
86476.............................................  Diazepam.
86510.............................................  Phentermine
                                                     hydrochloride.
86515.............................................  Phentermine
                                                     hydrochloride.
86529.............................................  Dicyclomine
                                                     hydrochloride;
                                                     phenobarbital.
86555.............................................  Phendimetrazine
                                                     tartrate.
86563.............................................  Dicyclomine
                                                     hydrochloride;
                                                     phenobarbital.
86564.............................................  Phenobarbital;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate; hyscyamine
                                                     hydrobromide.
86565.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86566.............................................  Dicyclomine
                                                     hydrochloride;
                                                     phenobarbital.
86581.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86591.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86625.............................................  Dicyclomine
                                                     hydrochloride.
86627.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86629.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86630.............................................  Piperidolate
                                                     hydrochloride;
                                                     phenobarbital.
86634.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86644.............................................  Piperidolate
                                                     hydrochloride.
86647.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86650.............................................  Anisotropine
                                                     methylbromide;
                                                     phenobarbital.
86654.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86655.............................................  Atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     phenobarbital;
                                                     scopolamine
                                                     hydrobromide.
86657.............................................  Phenobarbital;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86658.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86665.............................................  Phenobarbital;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86667.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86668.............................................  Phenobarbital;
                                                     belladonna alkaloid
                                                     malates, l-.
86669.............................................  Dicyclomine
                                                     hydrochloride.
86670.............................................  Atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     phenobarbital;
                                                     scopolamine
                                                     hydrobromide.
86671.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate.
86674.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86675.............................................  Butabarbital sodium;
                                                     simethicone;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     scopoamine.
86685.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86687.............................................  Phenobarbital;
                                                     belladonna extract.
86692.............................................  Amobarbital;
                                                     belladonna.
86694.............................................  Oxyphencyclimine
                                                     hydrochloride;
                                                     phenobarbital.
86696.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86701.............................................  Atropine sulfate;
                                                     phenobarbital.
86703.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86704.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86706.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86708.............................................  Cyproheptadine
                                                     hydrochloride.
86709.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86721.............................................  Procainamide
                                                     hydrochloride.
86770.............................................  Nitroglycerin.
86773.............................................  Triamcinolone
                                                     diacetate.
86774.............................................  Erythrityl
                                                     tetranitrate.
86775.............................................  Isosorbide
                                                     dinitrate.
86776.............................................  Pentaerythritol
                                                     tetranitrate.
86777.............................................  Nitroglycerin.
86779.............................................  Nitroglycerin.
86782.............................................  Nitroglycerin.
86783.............................................  Isosorbide
                                                     dinitrate.
86784.............................................  Pentaerythritol
                                                     tetranitrate.
86785.............................................  Pentaerythritol
                                                     tetranitrate.
86786.............................................  Isosorbide
                                                     dinitrate.

[[Page 35698]]

 
86789.............................................  Estradiol valerate.
86794.............................................  Dipyridamole.
86799.............................................  Atropine sulfate;
                                                     phenobarbital.
86838.............................................  Pentaerythritol
                                                     tetranitrate.
86839.............................................  Isosorbide
                                                     dinitrate.
86868.............................................  Chlorpromazine
                                                     hydrochloride.
86882.............................................  Hydrocortisone.
86897.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     hydrobromide;
                                                     atropine sulfate;
                                                     scopolamine
                                                     hydrobromide.
86921.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinum bromide.
86970.............................................  Aminophylline.
86976.............................................  Doxylamine
                                                     succinate;
                                                     pyridoxine
                                                     hydrochloride.
86991.............................................  Probenecid.
86999.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
87000.............................................  Hydralazine
                                                     hydrochloride.
87041.............................................  Phendimetrazine
                                                     tartrate.
87064.............................................  Piperazine citrate.
87069.............................................  Sulfisoxazole
                                                     acetyl.
87096.............................................  Phentermine
                                                     hydrochloride.
87097.............................................  Phentermine
                                                     hydrochloride.
87098.............................................  Phentermine
                                                     hydrochloride.
87099.............................................  Phentermine
                                                     hydrochloride.
87106.............................................  Ergotamine tartrate;
                                                     caffeine.
87112.............................................  Spironolactone.
87116.............................................  Reserpine;
                                                     chlorothiazide.
87123.............................................  Benzthiazide.
87124.............................................  Benzthiazide.
87125.............................................  Diphenhydramine
                                                     hydrochloride.
87134.............................................  Promethazine
                                                     hydrochloride.
87166.............................................  Phentolamine
                                                     hydrochloride.
87172.............................................  Theophylline.
87198.............................................  Belladonna alkaloid
                                                     malates, l-;
                                                     phenobarbital.
87379.............................................  Quinidine gluconate.
87443.............................................  Homatropine
                                                     methylbromide;
                                                     phenobarbital.
------------------------------------------------------------------------


    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14476 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P