[Federal Register Volume 61, Number 151 (Monday, August 5, 1996)]
[Notices]
[Pages 40649-40653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19804]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0257]
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of 87 New
Drug Applications, 18 Abbreviated Antibiotic Drug Applications, and 103
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 87 new drug applications (NDA's), 18 abbreviated antibiotic
applications (AADA's), and 103 abbreviated new drug applications
(ANDA's). The holders of the applications 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that the approval of the applications be withdrawn.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: September 4, 1996.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: The holders of the applications 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.
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Application no. Drug- Applicant
------------------------------------------------------------------------
NDA 6-54........................ Progstigmin Hoffmann-La Roche,
(neostigmine Inc., 340
bromide solution) Kingsland St.,
Opthalmic Nutley, NJ 07110-
Solution, 5%. 1199.
NDA 5-319....................... Pantopaque Alcon
(iophendylate) Laboratories,
Injection. Inc., 6201 South
Freeway, Fort
Worth, TX 76134-
2099.
NDA 6-135....................... Folic Acid........ Lilly Research
Laboratories,
Lilly Corporate
Center,
Indianopolis, IN
46285.
NDA 6-213....................... Propylthiouracil Do.
Tablets.
NDA 6-215....................... Delphicol Tablets Lederle
and Solution. Laboratories,
Pearle River, NY
10965.
NDA 6-333....................... Synophylate Central
(theophylline Pharmaceuticals,
sodium glycinate) Inc., 120 East
Elixir. Third St.,
Seymour, IN
47274.
NDA 6-386....................... Mol-Iron Liquid... Schering-Plough
Corp., 110 Allen
Rd., P.O. Box
276, Liberty
Corner, NJ 07938-
0276.
NDA 6-686....................... Dramamine Liquid.. Richardson-Vicks,
Inc., One Far
Mill Crossing,
Shelton, CT
06484.
NDA 6-911....................... Sulfisoxazole Roche
Syrup/Pediatric Pharmaceuticals,
Suspension. 340 Kingsland
St., Nutley, NJ
07110-1199.
NDA 8-082....................... Propion Gel....... Wyeth-Ayerst
Laboratories,
P.O. Box 8299,
Philadelphia, PA
19101-8299.
NDA 8-855....................... Milontin 500 Parke-Davis
milligram (mg) Pharmaceutical
Kapseals. Research, 2800
Plymouth Rd., Ann
Arbor, MI 48105.
NDA 8-951....................... Pagitane HCl Lilly Research
Tablets. Laboratories.
NDA 9-008....................... Salpix Contrast The R. W. Johnson
Medium. Pharmaceutical
Research
Institute, Rt.
202, Box 300,
Raritan, NJ 08869-
0602.
NDA 9-115....................... Serpasil Tablets Ciba-Geigy Corp.,
and Elixir. 556 Morris Ave.,
Summit, NJ 07901.
NDA 9-220....................... Di-Isopacin....... Consolidated
Midland Corp., 16-
20 Main St.,
Brewster, NY
10509.
NDA 9-268....................... Choledyl Tablets, Parke-Davis
Pediatric Syrup, Pharmaceutical
and Elixir,. Research.
NDA 9-296....................... Serpasil Ciba-Geigy Corp.
Apresoline.
NDA 9-309....................... Dionosil Oily..... Glaxo, Inc., Five
Moore Dr., P.O.
Box 13358,
Research Triangle
Park, NC 27709.
NDA 9-434....................... Serpasil Ciba-Geigy Corp.
Parenteral
Solution.
NDA 9-750...................... Valmid Capsules, Lilly Research
500 mg. Laboratories.
NDA 10-291...................... Cortril Soluble Pfizer, Inc., 235
Parenteral. East 42d St., New
York, NY 10017-
5755.
NDA 10-599...................... Tral Filmtab...... Pharmaceutical
Products
Division, Abbott
Laboratories, One
Abbott Park Rd.,
Abbott Park, IL
60064-3500.
NDA 10-670...................... ORINASE Tablets... The Upjohn Co.,
700 Portage Rd.,
Kalamazoo, MI
49001-0199.
NDA 10-710...................... Toleron Tablets Wallace
and Suspension. Laboratories,
Cranbury, NJ
08512.
NDA 10-776...................... DELTA-CORTEF Eye The Upjohn Co.
Drops, S.S..
NDA 10-911...................... BUCLADIN-S Tablets Zeneca, 1800
Concord Pike,
Wilmington, DE
19897.
[[Page 40650]]
NDA 11-078...................... Theruhistin Syrup. Wyeth-Ayerst
Laboratories.
NDA 11-837...................... Alpha Chymar...... Sola/Barnes-Hind,
810 Kifer Rd.,
Sunnyvale, CA
94086-5200.
NDA 11-878...................... Serpasil Esidrix.. Ciba-Geigy Corp.
NDA 13-157...................... Anhydron Tablets.. Lilly Research
Laboratories.
NDA 13-621...................... Pertofrane Rhone-Poulence
Capsules. Rorer
Pharmaceuticals,
Inc., 500 Arcola
Rd., P.O. Box
1200,
Collegeville, PA
19426-0107.
NDA 14-173...................... Proketazine Oral Wyeth-Ayerst
Suspension. Laboratories.
NDA 15-148...................... Colgate MFP Colgate-Palmolive
Flouride Co., P.O. Box
Toothpaste. 1343, 909 River
Rd., Piscataway,
NJ 08855-1343.
NDA 16-001...................... BENZTHIAZIDE Solvay
Tablets, 25 mg Pharmaceuticals,
and 50 mg. 901 Sawyer Rd.,
Marietta, GA
30062.
NDA 16-144...................... Ethamide Tablets.. Allergan, 2525
Dupont Dr., P.O.
Box 19534,
Irvine, CA 92713-
9534.
NDA 16-287...................... Kaon Sugar Coated Savage
Tablets. Laboratories,
Division of
Altana, Inc., 60
Baylis Rd.,
Melville, NY
11747.
NDA 16-749...................... Norlestrin 21 1/50 Parke-Davis
Tablets. Pharmaceutical
Research.
NDA 16-764...................... Stemex Oral Hoffman-LaRoche,
Tablets. Inc.
NDA 16-852...................... Norlestrin 21 2.5/ Parke-Davis
50 Tablets. Pharmaceutical
Research.
NDA 16-854...................... Norlestrin FE 2.5/ Do.
50 Tablets.
NDA 16-998...................... Uticort Cream..... Do.
NDA 17-226...................... SORBITRATE SA Zeneca.
Tablets, 40 mg.
NDA 17-421...................... Armohex The Dial Corp.,
Hexachlorophene 15191 North
Liquid Soap Ready Scottsdale Rd.,
to Use. Scottsdale, AZ
85260.
NDA 17-508...................... Lidocaine Fujisawa USA,
Hydrochloride Inc., Parkway
Injection. North Center,
Three Parkway
North, Deerfield,
IL 60015-2548.
NDA 17-546...................... Nipride Vials..... Hoffmann-La Roche,
Inc.
NDA 17-675...................... Bethanidine Medco Research,
Sulfate Tablets. Inc., P.O. Box
13886, Research
Triangle Park, NC
27709.
NDA 17-701...................... Lidocaine International
Hydrochloride Medication
Injection. Systems, Ltd.,
1886 Santa Anita
Ave., South El
Monte, CA 91733.
NDA 17-780...................... Heparin Sodium Pharmaceutical
Injection. Specialist
Associates, 9852
Cowden St.,
Philadelphia, PA
19115.
NDA 17-927...................... Globin Zinc Novo Nordisk
Insulin Injection. Pharmaceuticals,
Inc., 100
Overlook Center,
suite 200,
Princeton, NJ
08540-7810.
NDA 17-928...................... Protamine Zinc Do.
Insulin
Suspension.
NDA 18-370...................... Furosemide Superharm Corp.,
Tablets, 20 mg 600 Corporate
and 40 mg. Dr., suite 520,
Fort Lauderdale,
FL 33334.
NDA 18-382...................... Semilente Purified Novo Nordisk
Pork Prompt Pharmaceuticals,
Insulin Zinc Inc.
Suspension.
NDA 18-385...................... Ultralente Do.
Purified Beef
Extended Insulin
Zinc Suspension.
NDA 18-456...................... MICATIN Antifungal Advanced Care
Spray Powder. Products, Ortho
Pharmaceutical
Corp., Raritan,
NJ 08869.
NDA 18-457...................... MICATIN Antifungal Do.
Shaker Powder.
NDA 18-524...................... Purified Insulin Bristol-Myers
Semilente. Squibb, P.O. Box
4500, Princeton,
NJ 08543-4500.
NDA 18-527...................... Purified Insulin Do.
Ultralente.
NDA 18-539...................... Regular Iletin II. Lilly Research
Laboratories.
NDA 18-540...................... Lente Iletin II... Do.
NDA 18-541...................... NPH Iletin II..... Do.
NDA 18-542...................... Protamine, Zinc, Do.
and Ilentin --.
NDA 18-605...................... Azulfidine Oral Kabi Pharmacia, c/
Suspension. o Adria
Laboratories,
P.O. Box 16529,
Columbus, OH
43216-6529.
NDA 18-633...................... Fibocil Pulvules.. Lilly Research
Laboratories.
NDA 18-666...................... Fibocil Injection. Do.
NDA 18-747...................... Isoclor Timesule CIBA, Mack
Capsules. Woodbridge II,
581 Main St.,
Woodbridge, NJ
07095.
NDA 18-777...................... Novolin L......... Novo Nordisk
Pharmaceuticals,
Inc.
NDA 18-778...................... Novolin R......... Do.
NDA 18-928...................... Pentuss Controlled Fisons Corp., P.O.
Release Box 1710,
Suspension. Rochester, NY
14603.
NDA 18-954...................... 0.2% Lidocaine Abbott
Hydrochloride in Laboratories.
5% Dextrose
Injection.
NDA 19-005...................... Bretylium Tosylate Do.
in 5% Dextrose
Injection.
NDA 19-046...................... Normozide Schering Corp.,
Labetalol. Galloping Hill
Rd., Kenilworth,
NJ 07033.
NDA 19-441...................... Novolin 70/30..... Novo Nordisk
Pharmaceuticals,
Inc.
NDA 19-443...................... Sodium Bicardonate Abbott
Injection. Laboratories.
NDA 19-456...................... Pindac Pulvules... Leo Pharmaceutical
Products, Ltd. A/
S, 55
Industriparken,
DK-2750 Ballerup
Denmark.
NDA 19-564...................... Aminosyn II with Abbott
Electrolytes in Laboratories.
Dextrose
Injection.
NDA 19-565...................... Aminosyn II 5% in Do.
25% Dextrose.
NDA 19-693...................... Decabid........... Lilly Research
Laboratories.
NDA 50-003...................... Erythrocin Abbott
Stearate-Sulfas Laboratories.
Filmtab/
Erythromid
Filmtab.
NDA 50-069...................... TAO Chewable Pfizer, Inc.
Tablets.
NDA 50-072...................... Penbritin Wyeth-Ayerst
Injection. Laboratories.
[[Page 40651]]
NDA 50-126...................... Bicillin Oral Do.
Suspension.
NDA 50-198...................... Erythrocin Ethyl Abbott
Succinate-Sulfas Laboratories.
Chewable Tablets.
NDA 50-301...................... Veracillin Wyeth-Ayerst
Injection. Laboratories.
NDA 50-371...................... Ilotycin Sulfa.... Lilly Research
Laboratories.
NDA 50-481...................... Velosef for Apothecon, P.O.
Injection. Box 4500,
Princeton, NJ
08543-4500.
NDA 50-523...................... Vira-A 200 mg/ Parke-Davis
milliliter (mL) Pharmaceutical
Intravenous Research.
Infusion.
NDA 50-699...................... SUPRAX Chewable Lederle
Tablet. Laboratories.
AADA 60-075..................... Penicillin G Pfizer, Inc.
Potassium
Tablets, 200,000
Units, 250,000
Units, 400,000
Units, and
800,000 Units.
AADA 60-097..................... Bacitracin Do.
Ointment, 500
Units/Gram.
AADA 60-281..................... Neomycin and Do.
Polymyxin B
Sulfates and
Bacitracin
Ophthalmic
Ointment.
AADA 60-282..................... Sterile Bacitracin Do.
AADA 60-576..................... Mycolog II Cream.. Apothecon.
AADA 60-587..................... Penicillin G Pfizer, Inc.
Potassium for
Oral Solution.
AADA 60-726..................... Bacitracin Do.
Ophthalmic
Ointment.
AADA 60-728..................... Neomycin Sulfate Do.
and Bacitracin
Ointment.
AADA 60-877..................... Gentamicin Sulfate Shering Corp.
AADA 61-815..................... Penicillin V Pfizer, Inc.
Potassium for
Oral Solution.
AADA 61-836..................... Penicillin V Do.
Potassium
Tablets, 250 mg.
AADA 61-898..................... Ampicillin and Apothecon.
Probenecid for
Oral Suspension.
AADA 62-049..................... Ampicillin for Pfizer, Inc.
Oral Suspension.
AADA 62-050..................... Ampicillin Do.
Capsules.
AADA 62-422..................... Cephalothin Sodium Baxter Healthcare
Injection. Corp., Rt. 120
and Wilson Rd.,
Round Lake, IL
60073-0490.
AADA 62-494..................... Doxycycline Superpharm Corp.
Hyclate Tablets.
AADA 62-540..................... Tetracycline Do.
Hydrochloride
Capsules.
AADA 62-730..................... Cephalothin Sodium Baxter Healthcare
Injection. Corp.
ANDA 70-065..................... Sulfamethoxazole Superpharm Corp.
and Trimethoprim
Tablets, 400 mg/
80 mg.
ANDA 70-066..................... Sulfamethoxazole Superpharm Corp.
and Trimethoprim
Tablets, 800 mg/
160 mg.
ANDA 70-162..................... Tolazamide Barr Laboratories,
Tablets, 100 mg. Inc., Two Quaker
Rd., P.O. Box
2900, Pomona, NY
10970-0519.
ANDA 70-163..................... Tolazamide Do.
Tablets, 250 mg.
ANDA 70-164..................... Tolazamide Do.
Tablets, 500 mg.
ANDA 70-709..................... Ibuprofen Tablets, Superpharm Corp.
600 mg.
ANDA 70-926..................... Metoclopramide Do.
Hydrochloride
Tablets, 10 mg.
ANDA 71-245..................... Lorazepam Tablets, Do.
0.5 mg.
ANDA 71-246..................... Lorazepam Tablets, Do.
1 mg.
ANDA 71-247..................... Lorazepam Tablets, Do.
2 mg.
ANDA 71-319..................... Propoxyphene Do.
Napsylate and
Acetaminophen
Tablets, 100 mg/
650 mg.
ANDA 71-659..................... Flurazepam Do.
Hydrochloride
Capsules, 15 mg.
ANDA 71-660..................... Flurazepam Do.
Hydrochloride
Capsules, 30 mg.
ANDA 71-771..................... Propranolol Warner Chilcott
Hydrochloride and Laboratories, 182
Hydrochlorothiazi Tabor Rd., Morris
de Tablets, 40 mg/ Plains, NJ 07950.
25 mg.
ANDA 72-809..................... Meclofenamate Barr Laboratories,
Sodium Capsules, Inc.
100 mg.
ANDA 72-848..................... Meclofenamate Do.
Sodium Capsules,
50 mg.
ANDA 80-457..................... Reserpine Tablets, Halsey Drug Co.,
0.1 mg and 0.25 Inc., 1827
mg. Pacific St.,
Brooklyn, NY
11233.
ANDA 80-721..................... Reserpine Tablets, Do.
0.25 mg.
ANDA 80-744..................... Tripelennamine Do.
Hydrochloride
Tablets, 50 mg.
ANDA 80-854..................... Pyridoxone Lilly Research
Hydrochloride Laboratories.
Injection.
ANDA 80-855..................... Cyanocobalamin Do.
Injection.
ANDA 80-884..................... Ergocalciferol Do.
(Vitamin D)
Capsules, 1.25 mg.
ANDA 83-130..................... Ammonium Chloride Abbott
Injection. Laboratories.
ANDA 83-154..................... Lidocaine and Do.
Epinephrine
Injection.
ANDA 83-370..................... Dramamine Tablets. Richardson-Vicks,
Inc.
ANDA 83-393..................... Quinidine Sulfate ICN
Tablets, 200 mg. Pharmaceuticals,
Inc., ICN Plaza,
3300 Hyland Ave.,
Costa Mesa, CA
92626.
ANDA 83-471..................... Cortisone Acetate Barr Laboratories,
Tablets, 25 mg. Inc.
ANDA 83-644..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (yellow).
ANDA 83-684..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (white).
ANDA 83-686..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (gray).
ANDA 83-687..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (pink).
ANDA 83-944..................... Triamcinolone Apothecon.
Acetonide
Ointment, 0.5%.
ANDA 83-999..................... Hydrocortisone Barr Laboratories,
Tablets, 20 mg. Inc.
ANDA 84-031.................... Sulfisoxazole Do.
Tablets, 500 mg.
ANDA 84-177..................... Quinidine Sulfate Do.
Tablets, 200 mg.
ANDA 84-225..................... Secobarbital Do.
Sodium Capsules,
100 mg.
ANDA 84-230..................... Meprobamate Do.
Tablets, 600 mg.
[[Page 40652]]
ANDA 84-267..................... Triamcinolone Do.
Tablets, 4 mg.
ANDA 84-268..................... Triamcinolone Do.
Tablets, 8 mg.
ANDA 84-286..................... Triamcinolone Do.
Tablets, 2 mg.
ANDA 84-318..................... Triamcinolone Do.
Tablets, 2 mg.
ANDA 84-319..................... Triamcinolone Do.
Tablets, 4 mg.
ANDA 84-320..................... Triamcinolone Do.
Tablets, 8 mg.
ANDA 84-426..................... Prednisolone Do.
Tablets, 5 mg.
ANDA 84-468..................... Brompheniramine Do.
Maleate Tablets,
4 mg.
ANDA 84-579..................... Reserpine and Do.
Hydrochlorothiazi
de Tablets, 0.125
mg/50 mg.
ANDA 84-580..................... Reserpine and Do.
Hydrochlorothiazi
de Tablets, 0.125
mg/25 mg.
ANDA 84-721..................... Lidocaine Carlisle
Hydrochloride Laboratories,
Injection, 2%. Inc., 865 Merrick
Ave., Westbury,
NY 11590.
ANDA 84-731..................... Theophylline R. P. Scherer
Capsules, 100 mg, North America,
200 mg, and 250 2725 Scherer Dr.,
mg. St. Petersburg,
FL 33176-1016.
ANDA 84-771..................... Hydrochlorothiazid Barr Laboratories,
e Tablets, 50 mg Inc.
(yellow).
ANDA 84-831..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (green-
speckled).
ANDA 84-834..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (green).
ANDA 84-835..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg (pink).
ANDA 84-944..................... Lidocaine Carlisle
Ointment, 5% Laboratories,
(spearmint). Inc.
ANDA 84-946..................... Lidocaine Do.
Ointment, 5%
(mixed fruit).
ANDA 85-038..................... Quinidine Sulfate Eli Lilly and Co.
Tablets, 200 mg.
ANDA 85-068..................... Quinidine Sulfate Scherer
Tablets, 200 mg. Laboratories,
Inc., 2301 Ohio
Dr., suite 234,
Plano, TX 75093.
ANDA 85-103..................... Quinidine Sulfate Eli Lilly and Co.
Capsules, 200 mg.
ANDA 85-291..................... Acetaminophen and Geneva
Codeine Phosphate Pharmaceuticals,
Tablets, 300 mg/ Inc., 2555 West
30 mg. Midway Blvd.,
P.O. Box 446,
Broomfield, CO
80038-0446.
ANDA 85-353..................... Theophylline Central
Tablets, 100 mg Pharmaceuticals,
and 200 mg. Inc.
ANDA 85-928..................... Hydrocortisone Abbott
Sodium Succinate Laboratories.
for Injection.
ANDA 85-964..................... Acetaminophen and Geneva
Codeine Phosphate Pharmaceuticals,
Tablets, 300 mg/ Inc.
60 mg.
ANDA 86-586..................... Diphenhydramine Halsey Drug Co.,
Hydrochloride Inc.
Elixir, 12.5 mg/5
mL.
ANDA 87-121..................... Tolbutamide Barr Laboratories,
Tablets, 500 mg. Inc.
ANDA 87-189..................... Sulfamethoxazole Do.
Tablets, 500 mg.
ANDA 87-247..................... Chlorthalidone Superpharm Corp.
Tablets, 50 mg.
ANDA 87-982..................... Nitroglycerin Zenith
Extended-Release Laboratories,
Capsules, 2.5 mg. Inc., 140 Legrand
Ave., Northvale,
NJ 07647.
ANDA 87-983..................... Nitroglycerin Do.
Extended-Release
Capsules, 6.5 mg.
ANDA 88-213..................... Triprolidine and Halsey Drug Co.,
Pseudoephedrine Inc.
Hydrochlorides
Syrup, 1.25 mg/
30 mg per 5 mL.
ANDA 88-297..................... Aminophylline Barr Laboratories,
Tablets, 100 mg. Inc.
ANDA 88-298..................... Aminophylline Do.
Tablets, 200 mg.
ANDA 88-416..................... Dipyridamole Do.
Tablets, 25 mg.
ANDA 88-417..................... Dipyridamole Do.
Tablets, 50 mg.
ANDA 88-418..................... Dipyridamole Do.
Tablets, 75 mg.
ANDA 88-503..................... Theophylline Forest
Controlled- Pharmaceuticals,
Release Tablets, Inc., 909 Third
100 mg. Ave., New York,
NY 10022-4731.
ANDA 88-504..................... Theophylline Do.
Controlled-
Release Tablets,
200 mg.
ANDA 88-505..................... Theophylline Do.
Controlled-
Release Tablets,
300 mg.
ANDA 88-695..................... Chlorpropamide Superpharm Corp.
Tablets, 250 mg.
ANDA 88-735..................... Triprolidine Halsey Drug Co.,
Hydrochloride Inc.
Syrup, 1.25 mg/ 5
mL.
ANDA 88-794..................... Hydroxyzine Superpharm Corp.
Hydrochloride
Tablets, 10 mg.
ANDA 88-795..................... Hydroxyzine Do.
Hydrochloride
Tablets, 25 mg.
ANDA 88-796..................... Hydroxzine Do.
Hydrochloride
Tablets, 50 mg.
ANDA 88-812..................... Chlorpropamide Barr Laboratories,
Tablets, 100 mg Inc.
(white).
ANDA 88-813..................... Chlorpropamide Do.
Tablets, 250 mg
(white).
ANDA 88-827..................... Hydrochlorothiazid Superpharm Corp.
e Tablets, 25 mg.
ANDA 88-828..................... Hydrochlorothiazid Do.
e Tablets, 50 mg.
ANDA 88-829..................... Hydrochlorothiazid Do.
e Tablets, 100 mg.
NADA 88-865..................... Prednisone Do.
Tablets, 5 mg.
ANDA 88-866..................... Prednisone Do.
Tablets, 10 mg.
ANDA 88-867..................... Prednisone Do.
Tablets, 20 mg.
ANDA 88-893..................... Tolbutamide Do.
Tablets, 500 mg.
ANDA 88-962..................... Diphenoxylate Do.
Hydrochloride and
Atropine Sulfate
Tablets, 2.5 mg/
0.025 mg.
ANDA 89-103..................... Thioridazine Do.
Hydrochloride
Tablets, 10 mg.
ANDA 89-104..................... Thioridazine Do.
Hydrochloride
Tablets, 25 mg.
ANDA 89-105..................... Thioridazine Do.
Hydrochloride
Tablets, 50 mg.
ANDA 89-177..................... Folic Acid Barr Laboratories,
Tablets, 1 mg. Inc.
ANDA 89-179..................... Diphenhydramine Halsey Drug Co.,
Hydrochloride Inc.
Syrup, 12.5 mg/ 5
mL.
[[Page 40653]]
ANDA 89-184..................... Acetaminophen and Superpharm Corp.
Codeine Phosphate
Tablets, 300 mg/
30 mg.
ANDA 89-185..................... Acetaminophen and Do.
Codeine Phosphate
Tablets, 300 mg/
60 mg.
ANDA 89-199..................... Cyproheptadine Halsey Drug Co.,
Hydrochloride Inc.
Syrup, 2 mg/ 5 mL.
ANDA 89-362..................... Lidocaine Abbott
Hydrochloride Laboratories.
Injection, 20%.
ANDA 89-446..................... Chlorpropamide Barr Laboratories,
Tablets, 100 mg Inc.
(blue).
ANDA 89-447..................... Chlorpropamide Do.
Tablets, 250 mg
(blue).
------------------------------------------------------------------------
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 applications listed above, and all amendments and
supplements thereto, is hereby withdrawn, effective September 4, 1996.
Dated: July 9, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-19804 Filed 8-02-96; 8:45 am]
BILLING CODE 4160-01-F