[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Notices]
[Pages 26191-26193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12613]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0285]
Sanofi Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
21 New Drug Applications and 62 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 21 new drug applications (NDA's) and 62 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requested that the approval of the applications be withdrawn.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: June 11, 1998.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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
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NDA 4-496 Pipanol Powder and Tablets (trihyphenidyl) Sanofi Pharmaceuticals, Inc., 90 Park
Ave., New York, NY 10016.
NDA 6-328 Isuprel (isoproterenol hydrochloride) Do.
Sublingual Tablets, 10 milligrams (mg)
and 15 mg
NDA 7-514 Insulin, NPH Iletin Eli Lilly and Co., Lilly Corporate
Center, Indianapolis, IN 46285.
NDA 8-256 Insulin Do.
NDA 8-717 Acetaminophen Tablets USP (acetaminophen Roxane Laboratories, Inc., P.O. Box
tablets) 16532, Columbus, OH 43216-6532.
NDA 8-847 Sucostrin (succinylcholine chloride Apothecon, Inc., P.O. Box 4500,
injection) Princeton, NJ 08543-4500.
NDA 8-983 Arfonad (trimethaphan camsylate) Ampules Hoffmann-La Roche, Inc., 40 Kingsland
St., Nutley, NJ 07110-1199.
NDA 9-088 Neothylline (dyphylline) injection TEVA Pharmaceuticals USA (formerly Lemmon
Co.), 650 Cathill Rd., Sellersvile, PA
18960.
NDA 9-300 Insulin, Lente Iletin I Eli Lilly and Co.
NDA 9-410 Lotusate Tablets and and Capsules Sanofi Pharmaceuticals, Inc.
(talbutal)
NDA 9-479 Jayne's Liquid Vermifuge (piperazine Do.
hexahydrate)
[[Page 26192]]
NDA 10-966 Insulin, Ultralente Eli Lilly and Co.
NDA 10-967 Insulin, Semilente Do.
NDA 11-446 Sterane (prednisolone acetate injection) Pfizer, Inc., 235 East 42d St., New York,
Intramuscular and Intra-Articular NY 10017-5755.
NDA 11-724 Fenarol Tablets (chlormezanone) Sanofi Pharmaceuticals, Inc.
NDA 17-108 Methadone HydrochlorideTablets, 2.5 mg, 5 Eon Labs Manufacturing, Inc., 227-15
mg, 10 mg, and 40 mg North Conduit Ave., Laurelton, NY 11413.
NDA 17-446 pHisoScrub (hexachlorophene) Sanofi Pharmaceuticals, Inc.
NDA 18-217 Suprol (suprofen) Capsules, 200 mg R. W. Johnson Pharmaceutical Research
Institute, 920 Rt. 202 South, P.O. Box
300, Raritan, NJ 08869-0602.
NDA 18-660 10% Travamulsion (Intravenous Fat Baxter Healthcare Corp., Rt. 120 and
Emulsion) Wilson Rd., Round Lake, IL 60073.
NDA 18-719 Modrastane (trilostane) Capsules Sanofi Pharmaceuticals, Inc.
NDA 19-358 Azo Gantrisin (sulfisoxazole and Hoffman-La Roche, Inc.
phenazopyridine hydrochloride) Tablets
ANDA 60-734 BACIGUENT Ophthalmic Ointment (Bacitracin Pharmacia & Upjohn Co., 7000 Portage Rd.,
Ophthalmic Ointment, USP) Kalamazoo, MI 49001-0199.
ANDA 62-036 Aerosporin (Polymyxin B Sulfate Sterile Glaxo Wellcome, Inc., Five Moore Dr.,
Powder) P.O. Box 13398, Research Triangle Park,
NC 27709.
ANDA 62-363 Cleocin T Topical Solution (Clindamycin Pharmacia & Upjohn Co.
Phosphate Topical Solution, USP)
ANDA 62-479 Doxycycline Hyclate Capsules USP, 50 mg Purepac Pharmaceutical Co. 200 Elmora
and 100 mg (Base) Ave., Elizabeth, NJ 07207.
ANDA 62-913 Clindamycin Phosphate Injection USP, 150 Marsam Pharmaceuticals, Inc., Bldg. 31,
mg/milliliter (mL) Olney Ave., P.O. Box 1022, Cherry Hill,
NJ 08034.
ANDA 70-053 Betamethasone Valerate Cream USP, 0.1% Clay-Park Labs, Inc., 1700 Bathgate Ave.,
Bronx, NY 10457.
ANDA 70-829 Methyldopa and Hydrochlorothiazide Tablets Invamed, Inc., 2400 Rt. 130 North,
USP, 250 mg/15 mg Dayton, NJ 08810.
ANDA 70-830 Methyldopa and Hydrochlorothiazide Tablets Do.
USP, 250 mg/25 mg
ANDA 70-850 Metoclopramide Tablets USP, 10 mg Do.
ANDA 70-949 Metoclopramide Oral Solution USP, Eq. 5 mg Morton Grove Pharmaceuticals, Inc., 6451
Base/5 mL West Main St., Morton Grove, IL 60053.
ANDA 71-071 Haloperidol Tablets USP, 0.5 mg Purepac Pharmaceutical Co.
ANDA 71-072 Haloperidol Tablets USP, 1 mg Do.
ANDA 71-073 Haloperidol Tablets USP, 2 mg Do.
ANDA 71-074 Haloperidol Tablets USP, 5 mg Do.
ANDA 71-075 Haloperidol Tablets USP, 10 mg Do.
ANDA 71-076 Haloperidol Tablets USP, 20 mg Do.
ANDA 71-658 Propranolol Hydrochloride Tablets USP, 10 Invamed, Inc.
mg
ANDA 71-687 Propranolol Hydrochloride Tablets USP, 20 Do.
mg
ANDA 71-688 Propranolol Hydrochloride Tablets USP, 40 Do.
mg
ANDA 71-689 Propranolol Hydrochloride Tablets USP, 80 Do.
mg
ANDA 71-811 Naloxone Hydrochloride Injection USP, 0.4 Marsam Pharmaceuticals, Inc.
mg/mL
ANDA 71-812 Methyldopate Hydrochloride Injection USP, Do.
50 mg/mL
ANDA 71-938 Ibuprofen Tablets USP, 800 mg Invamed, Inc.
ANDA 72-064 Ibuprofen Tablets USP, 400 mg Do.
ANDA 72-065 Ibuprofen Tablets USP, 600 mg Do.
ANDA 72-109 Doxepin Hydrochloride Capsules, 25 mg Purepac Pharmaceutical Co.
ANDA 72-197 Propranolol Hydrochloride Tablets USP, 60 Invamed, Inc.
mg
ANDA 72-198 Propranolol Hydrochloride Tablets USP, 90 Do.
mg
ANDA 72-233 Verapamil Hydrochloride Injection USP, 2.5 Marsam Pharmaceuticals, Inc.
mg/mL (ampuls)
ANDA 72-371 Diazepam Injection USP, 5 mg/mL, 2 mL Do.
(ampul)
ANDA 72-436 Metoclopramide Tablets USP, 5 mg Invamed, Inc.
ANDA 72-516 Haloperidol Injection USP, 5 mg/mL, 1 mL Marsam Pharmaceuticals, Inc.
(ampul)
ANDA 72-517 Haloperidol Injection USP, 5 mg/mL, 10 mL Do.
(vial)
ANDA 73-054 Doxepin Hydrochloride Capsules, 10 mg Purepac Pharmaceutical Co.
ANDA 73-055 Doxepin Hydrochloride Capsules, 50 mg Do.
ANDA 73-098 PEG-Lyte (PEG 3350 and Electrolytes for Invamed, Inc.
Oral Solution USP)
ANDA 73-485 Verapamil Hydrochloride Injection USP, 2.5 Marsam Pharmaceuticals, Inc.
mg/mL (vials)
ANDA 74-125 Pindolol Tablets USP, 5 mg and 10 mg Purepac Pharmaceutical Co.
ANDA 74-302 Albuterol Sulfate Syrup, 2 mg (base)/5 mL Mova Pharmaceutical Corp., P.O. Box 8639,
Caguas, PR 00726.
ANDA 74-510 Etoposide Injection 20 mg/mL, 50 mL Gensia Laboratories, 19 Hughes, Irvine,
Pharmacy Bulk Package CA 92718-1902.
ANDA 81-222 ADRUCIL (Flourouracil Injection, USP) 500 Pharmacia & Upjohn Co.
mg/10 mL Ampuls
[[Page 26193]]
ANDA 81-242 FOLEX PFS (Methotrexate Sodium Injection, Do.
USP) 25 mg/mL
ANDA 83-187 Afaxin (brand of vitamin A Palmitate) Sanofi Pharmaceuticals, Inc.
ANDA 83-237 Diphenhydarmine Hydrochloride Elixir USP Purepac Pharmaceutical Co.
ANDA 83-278 Propoxyphene Hydrochloride Capsules USP, Do.
65 mg
ANDA 83-856 ESTRATAB (Esterified Estrogens Tablets, Solvay Pharmaceuticals, Inc., 901 Sawyer
USP) 1.25 mg Rd., Marietta, GA 30062.
ANDA 83-921 Elixophyllin (Theophylline Soft Gelatin Forest Laboratories, Inc., 909 Third
Capsules, 200 mg) Ave., New York, NY 10022-4731.
ANDA 84-003 Quinidine Sulfate Tablets USP, 200 mg Purepac Pharmaceutical Co.
ANDA 85-545 Elixophyllin (Theophylline Soft Gelatin Forest Laboratories, Inc.
Capsules, 100 mg)
ANDA 86-826 Elixophyllin SR (Theophylline Extended- Do.
Release Capsules, USP) 125 mg and 250 mg
ANDA 87-999 Spironolactone and Hydrochlorothiazide Purepac Pharmaceutical Co.
Tablets USP, 25 mg/25 mg
ANDA 89-284 Procainamide Hydrochloride Extended- Invamed, Inc.
Release Tablets USP, 500 mg
ANDA 89-463 Promethazine Hydrochloride Injection USP, Marsam Pharmaceuticals, Inc.
25 mg/mL
ANDA 89-477 Promethazine Hycrochloride Injection USP, Do.
50 mg/mL
ANDA 89-501 Phenytoin Sodium Injection USP, 50 mg/mL, Do.
2 mL (ampul)
ANDA 89-511 Codaphen (Acetaminophen and Codeine Roxane Laboratories, Inc.
Phosphate Tablets USP) 500 mg/15 mg
ANDA 89-512 Codaphen (Acetaminophen and Codeine Do.
Phosphate Tablets USP) 500 mg/30 mg
ANDA 89-513 Codaphen (Acetaminophen and Codeine Do.
Phosphate Tablets USP) 500 mg/60 mg
ANDA 89-563 Chlorpromazine Hydrochloride Injection Marsam Pharmaceuticals, Inc.
USP, 25 mg/mL
ANDA 89-675 Prochlorperazine Edisylate Injection USP, Do.
5 mg/mL
ANDA 89-779 Phenytoin Sodium Injection USP, 50 mg/mL, Do.
2 mL and 5 mL (vials)
ANDA 89-849 Methocarbamol Injection USP, 100 mg/mL Do.
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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 in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
June 11, 1998.
Dated: April 28, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-12613 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F
