[Federal Register Volume 60, Number 80 (Wednesday, April 26, 1995)]
[Notices]
[Pages 20499-20501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10272]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0101]
Warren Teed Pharmaceuticals, Inc., et al.; Withdrawal of Approval
of 107 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 107 abbreviated new drug applications (ANDA's). The holders of the
ANDA's notified the agency in writing that the drug products were no
longer marketed and requested that the approval of the applications be
withdrawn.
EFFECTIVE DATE: May 26, 1995.
FOR FURTHER INFORMATION CONTACT: Carolyn C. Harris, Center for Drug
Evaluation and Research (HFD-360), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: The holders of the ANDA's listed in the
table in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications. The applicants have also, by their request, waived their
opportunity for a hearing.
------------------------------------------------------------------------
ANDA No. Drug Applicant
------------------------------------------------------------------------
83-076................. Sulfasalazine, 500 Warren Teed
milligrams (mg). Pharmaceuticals,
Inc., Columbus, OH
43215.
83-078................. Chlorpheniramine Anabolic, Inc., P.O.
Maleate Tablets, 4 mg. Box C-19508, Irvine,
CA 92713.
83-135................. Lidocaine Hydrochloride G. D. Searle and Co.,
Injection, U.S.P., 1% P.O. Box 5110,
and 2%. Chicago, IL 60680.
83-168................. Hydrocortisone Liquid, Dermik Laboratories,
1% and 2 1/2%. Inc., 500 Arcola Rd.,
P.O. Box 1200,
Collegeville, PA
19426-0107.
83-169................. Hydrocortisone Gel, 1% Do.
and 2 1/2%.
83-184................. Propoxyphene Smith, Kline & French,
Hydrochloride One Franklin Plaza,
Capsules, 65 mg. P.O. Box 7929,
Philadelphia, PA
19101.
83-275................. Diphenhydramine Anabolic, Inc.
Hydrochloride
Capsules, U.S.P., 50
mg.
83-301................. Pentobarbital Sodium Purepac
Capsules, 100 mg. Pharmaceutical, Co.,
200 Elmora Ave.,
Elizabeth, NJ 07207.
83-313................. Triamcinolone Acetonide Dermik Laboratories,
Ointments, 0.025%, Inc.
0.1%, and 0.5%.
83-314................. Triamcinolone Acetonide Do.
Creams, 0.025%, 0.1%,
and 0.5%.
83-363................. Metaraminol Bitartrate Elkins-Sinn, Inc., Two
Injection, U.S.P., 10 Esterbrook Lane,
mg/milliliters (mL). Cherry Hill, NJ 08003-
4099.
83-554................. Hydrochlorothiazide Smith, Kline & French.
Tablets, 50 mg.
83-567................. Diphenhydramine West-Ward
Hydrochloride Pharmaceutical Corp.,
Capsules, 50 mg. 465 Industrial Way,
West, Eatontown, NJ
07724.
83-625................. Tripelennamine Warner-Lambert, 201
Hydrochloride Tablets, Tabor Rd., Morris
U.S.P., 25 mg. Plains, NJ 07950.
83-626................. Tripelennamine Do.
Hydrochloride Tablets,
U.S.P., 50 mg.
84-125................. Dextroamphetamine Purepac
Sulfate Tablets, 5 mg Pharmaceutical, Co.
and 10 mg.
84-239................. Hydrocortisone Tablets, Warner-Lambert.
10 mg.
84-240................. Prednisone Tablets, 5 Do.
mg.
84-242................. Prednisolone Tablets, 5 Do.
mg.
84-530................. Aminophylline Tablets, The Vale Chemical Co.,
200 mg. Inc., Allentown, PA
18102.
84-531................. Aminophylline Tablets, Do.
100 mg.
84-601................. Chlordiazepoxide Mylan Pharmaceuticals,
Hydrochloride Inc., P.O. Box 4310,
Capsules, 10 mg. 781 Chestnut Ridge
Rd., Morgantown, WV
26505-4310.
84-699................. Aminophylline Tablets, Purepac
100 mg. Pharmaceutical, Co.
84-739................. Theophylline Elixir, 80 Roxane Laboratories,
mg/15 mL. Inc., 1809 Wilson
Rd., Columbus, OH
43228.
84-880................. Hydrochlorothiazide Mylan Pharmaceuticals,
Tablets, 25 mg and 50 Inc.
mg.
85-112................. Hydrochlorothiazide Do.
Tablets, 50 mg.
85-195................. Meclizine Hydrochloride Circa Pharmaceuticals,
Tablets, 12.5 mg. 15 Grand Park Blvd.,
Athens, OH 45701.
85-375................. Acetaminophen Capsules, McNeil Pharmaceutical,
500 mg Oxycodone Welsh and Mckeon
Hydrochloride Rds., Spring House,
Capsules, 4.5 mg PA 19477-0776.
Oxycodone
Terephthalate
Capsules, 0.38 mg.
85-534................. Sulfisoxazole Tablets, Chelsea Laboratories,
500 mg. Inc., 896 Orlando
Ave., West Hempstead,
NY 11552.
85-564................. Aminophylline Tablets, Do.
200 mg.
85-567................. Aminophylline Tablets, Do.
100 mg.
[[Page 20500]]
85-667................. Hydrocodone Bitartrate Knoll Pharmaceutical,
Tablets, 5 mg 30 North Jefferson
Acetaminophen Tablets, Rd., Whippany, NJ
500 mg. 07981.
85-867................. Secobarbital Sodium Purepac
Capsules, U.S.P., 100 Pharmaceutical, Co.
mg.
85-892................. Dextroamphetamine Phoenix
Sulfate Tablets, 10 mg. Pharmaceutical, Inc.,
111 Leuning St.,
South Hackensack, NJ
07606.
86-044................. Isosorbide Dinitrate Circa Pharmaceuticals.
Tablets, 10 mg.
86-049................. Brompheniramine Maleate Purepac Pharmaceutical
Tablets, 4 mg. Co.
86-170................. Hydrocortisone Cream,1% Stiefel Laboratories,
Inc., 2801 Ponce De
Leon Blvd., Coral
Gables, FL 33134.
86-202................. Procaine Hydrochloride G. D. Searle and Co.
Injection, 1% and 2%.
86-205................. Ammonium Chloride Do.
Injection, 3
milliquivalent (meq)/
mL.
86-219................. Potassium Chloride Do.
Injection, U.S.P., 10
meq/10 mL, 20 meq/10
mL, 30 meq/mL, and 40
meq/10 mL.
86-220................. Potassium Chloride G. D. Searle and Co.
Injection.
86-302................. Isosorbide Dinitrate Purepac
Tablets, 10 mg. Pharmaceutical, Co.
86-304................. Isosorbide Dinitrate Do.
Tablets, 5 mg.
86-369................. Hydrochlorothiazide Smith, Kline & French.
Tablets, 25 mg.
86-418................. Metaraminol Bitartrate McGaw Inc., P.O. Box
Injection, U.S.P.. 19791, Irvine, CA
92713-9791.
86-824................. Hydrocortisone Lotion, Pharmaceutical
0.5%. Associates, Inc.,
P.O. Box 128,
Conestee, SC 29636.
86-858................. Isosorbide Dinitrate Lederle Labs, One
Tablets, U.S.P., 5 mg. Cyanamid Co., Wayne,
NJ 07470-8426.
86-862................. Isosorbide Dinitrate Do.
Tablets, U.S.P., 10 mg.
86-981................. Dipyridamole Tablets, Circa Pharmaceuticals.
Coated, 25 mg.
87-085................. Hydralazine Mylan Pharmaceuticals,
Hydrochloride Tablets, Inc.
25 mg
Hydrochlorothiazide
Tablets, 15 mg
Reserpine Tablets, 0.1
mg.
87-163................. Isosorbide Dinitrate D. M. Graham
Chewable Tablets, 5 mg. Laboratories, Inc.,
Hobart, NY 13788.
87-415................. Isosorbide Dinitrate Eon Labs
Capsules T.R., 40 mg, Manufacturing, Inc.,
Green & Clear. 227-15 North Conduit
Ave., Laurelton, NY
11413.
87-474................. Isosorbide Dinitrate Ascot Hospital
Oral Tablets, 5 mg. Pharmaceuticals,
Inc., 8055 North
Ridgeway Ave.,
Skokie, IL 60076.
87-475................. Isosorbide Dinitrate Do.
Oral Tablets, 10 mg.
87-476................. Isosorbide Dinitrate Do.
Oral Tablets, 20 mg.
87-478................. Isosorbide Dinitrate Do.
Sublinqual Tablets, 5
mg.
87-484................. Nitroglycerine TD Do.
Capsules, 2.5 mg.
87-485................. Nitroglycerine TD Do.
Capsules, 6.5 mg.
87-486................. Isosorbide Dinitrate SR Do.
Capsules, 40 mg.
87-512................. Chlordiazepoxide Do.
Hydrochloride
Capsules, 25 mg.
87-514................. Triprolidine Pharmaceutical
Hydrochloride Syrup, Associates, Inc.
1.25 mg/5 mL.
87-517................. Brompheniramine Maleate Do.
Elixir, 2 mg/5 mL.
87-518................. Promethazine Do.
Hydrochloride Syrup,
6.25 mg/5 mL.
87-520................. Chlorpheniramine Do.
Maleate Syrup, 2 mg/5
mL.
87-522................. Aminophylline Tablets, Ascot Hospital
100 mg. Pharmaceuticals, Inc.
87-523................. Aminophylline Do.
Tablets,200 mg.
87-524................. Chlordiazepoxide Do.
Hydrochloride
Capsules, 10 mg.
87-525................. Chlordiazepoxide Do.
Hydrochloride
Capsules, 5 mg.
87-539................. Hydrochlorothiazide Do.
Tablets, 25 mg.
87-540................. Hydrochlorothiazide Do.
Tablets, 50 mg.
87-541................. Tolbutamide Tablets, Do.
500 mg.
87-542................. Procainamide Do.
Hydrochloride
Capsules, 250 mg.
87-543................. Procainamide Do.
Hydrochloride
Capsules, 500 mg.
87-621................. Aminophylline G. D. Searle and Co.
Injection, 25 mg/mL.
87-660................. Methocarbamol Tablets, Ascot Hospital
500 mg. Pharmaceuticals, Inc.
87-661................. Methocarbamol Do.
Tablets,750 mg.
87-662................. Sulfamethoxazole Do.
Tablets, 500 mg.
87-663................. Propantheline Bromide Do.
Tablets, 15 mg.
87-685................. Cyproheptadine Do.
Hydrochloride Tablets,
4 mg.
87-686................. Acetazolamide Tablets, Do.
250 mg.
87-687................. Spironolactone Do.
Tablets,25 mg.
87-697................. Procainamide Do.
Hydrochloride
Capsules, 375 mg.
87-698................. Chlorthalidone Tablets, Do.
25 mg.
87-699................. Chlorthalidone Tablets, Do.
50 mg.
87-734................. Nitroglycerin Oral Merrell Dow
Transmucosal Long Pharmaceuticals,
Acting Tablets, 1 mg. Inc., 2110 East
Galbraith Rd., P.O.
Box 156300,
Cincinnati, OH 45215-
6300.
87-778................. Dimenhydrinate Tablets, Republic Drug Co.,
50 mg. Inc., 175 Great Arrow
Ave., Buffalo, NY
14207.
87-934................. Diphenoxylate Ascot Hospital
Hydrochloride Tablets, Pharmaceuticals, Inc.
2.5 mg Atropine
Sulfate Tablets, 0.025
mg.
88-005................. Isosorbide Dinitrate Unit Dose
Sublingual Tablets, 5 Laboratories, 1718
mg. Northrock Court,
Rockford, IL 61103.
88-006................. Isosorbide Dinitrate Do.
Tablets, Oral, 10 mg.
88-025................. Spironolactone with Ascot Hospital
Hydrochlorothiazide Pharmaceuticals, Inc.
Tablets, 25 mg/25 mg.
[[Page 20501]]
88-067................. Orphenadrine Citrate S. Do.
R. Tablets, 100 mg.
88-117................. Triprolidine West-Ward
Hydrochloride Tablets, Pharmaceutical Corp.
2.5 mg Pseudoephedrine
Hydrochloride Tablets,
60 mg.
88-199................. Folic Acid Tablets, 1 Unit Dose
mg. Laboratories.
88-256................. Meclizine Hydrochloride Do.
Tablets, 12.5 mg.
88-257................. Meclizine Hydrochloride Do.
Tablets, 25 mg.
88-288................. Bethanechol Chloride Ascot Hospital
Tablets, 10 mg. Pharmaceuticals, Inc.
88-289................. Bethanechol Chloride Do.
Tablets, 25 mg.
88-307................. Thioridazine Geneva
Hydrochloride Oral Pharmaceuticals,
Concentrate, 30 mg/ Inc., 2555 West
milliliters (mL). Midway Blvd.,
Broomfield, CO 80038-
0446.
88-308................. Thioridazine Do.
Hydrochloride Oral
Concentrate, 100 mg/mL.
88-318................. Triprolidine Circa Pharmaceuticals.
Hydrochloride Tablets,
2.5 mg Pseudoephedrine
Hydrochloride Tablets,
60 mg.
88-332................. Thioridazine Mylan Pharmaceuticals,
Hydrochloride Tablets, Inc.
10 mg.
88-333................. Thioridazine Do.
Hydrochloride Tablets,
25 mg.
88-334................. Thioridazine Do.
Hydrochloride Tablets,
50 mg.
88-335................. Thioridazine Do.
Hydrochloride Tablets,
100 mg.
88-582................. Quinidine Gluconate Ascot Hospital
Sustained Release Pharmaceuticals, Inc.
Tablets, 324 mg.
88-646................. Methocarbamol Tablets, Roxane Laboratories,
500 mg. Inc.
89-079................. Nitroglycerin Ascot Hospital
Controlled Release Pharmaceuticals, Inc.
Capsules, 9 mg.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research (21 CFR 5.82),
approval of the ANDA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective on May 26, 1995.
Dated: April 10, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-10272 Filed 4-25-95; 8:45 am]
BILLING CODE 4160-01-F