[Federal Register Volume 65, Number 54 (Monday, March 20, 2000)]
[Notices]
[Pages 14983-14985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-0988]
Lilly Research Laboratories et al.; Withdrawal of Approval of 22
New Drug Applications and 36 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 22 new drug applications (NDA's) and 36 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requested that the approval of the applications be withdrawn.
DATES: Effective April 19, 2000.
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 6-139 Surfacaine (cyclomethycaine). Lilly Research Laboratories, Lilly Corporate Center,
Indianapolis, IN 46285.
NDA 6-904 Terfonyl (trisulfapyrimidines) Tablets and Oral Suspension. Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-
4000.
NDA 9-357 Rau-Sed (reserpine) Tablets. Do.
NDA 9-523 Tyzine 0.1% (tetrahydrozoline HCl). Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755.
NDA 9-941 Tyzine 0.05% (tetrahydrozoline HCl) Pediatric Nasal Drops. Do.
NDA 10-520 Leritine (anileridine HCl) Injection Merck & Co., Inc., P.O. Box 4, BLA-20, West Point, PA 19486.
NDA 11-028 Hydeltrasol (prednisolone sodium phosphate) Sterile Do.
Ophthalmic Ointment, 0.25%.
NDA 11-178 Isuprel (isoproterenol hydrochloride) Mistometer. Sanofi Winthrop, Inc., 90 Park Ave., New York, NY 10016-
1389.
NDA 11-602 Kenalog (triamcinolone acetonide) Lotion. Bristol-Myers Squibb Co.
NDA 12-335 Forhistal (dimethindene maleate) Tablets. Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover,
NJ 07936-1080.
NDA 12-337 Forhistal (dimethindene maleate) Syrup. Do.
NDA 12-338 Forhistal (dimethindene maleate) Pediatric Drops. Do.
NDA 16-755 Diapid (Lypressin Nasal Solution USP) Nasal Spray. Novartis Pharmaceuticals Corp.
NDA 16-990 Intal (Cromolyn Sodium for Inhalation USP) Capsules. Rhone-Poulenc Rorer Pharmaceuticals, Inc., 500 Arcola Rd.,
P.O. Box 1200, Collegeville, PA 19426-0107.
NDA 17-605 Xylo-Pfan (Xylose USP) Powder. Savage Laboratories, 60 Baylis Rd., Melville, NY 11747.
NDA 19-215 FEMSTAT (butoconazole nitrate) 2% Vaginal Cream Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-
(prescription). 1199.
NDA 19-359 FEMSTAT (butoconazole nitrate) Suppositories, 100 milligrams Do.
(mg).
[[Page 14984]]
NDA 20-750 Tilade (nedocromil sodium inhalation solution) Nebulizer Rhone-Poulenc Rorer Pharmaceuticals, Inc.
Solution.
NDA 50-128 Bicillin (penicillin G benzathine) Tablets. Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA
19101-8299.
NDA 50-306 GEOPEN (carbenicillin disodium) IM/IV. Pfizer, Inc.
NDA 50-318 Kenalog-S Nasal Spray (neomycin sulfate-gramicidin and Bristol-Myers Squibb Co.
triamcinolone acetonide with phenylephrine)
NDA 50-518 Meclan (meclocycline sulfosalicylate) Cream, 1%. Johnson & Johnson Consumer Companies, Inc., 199 Grandview
Rd., Skillman, NJ 08558-9418.
ANDA 60-124 Strycin (streptomycin) Syrup. Bristol-Myers Squibb Co.
ANDA 60-513 Streptomycin Sulfate Injection USP. Do.
ANDA 60-933 Spectrocin (Neomycin Sulfate and Gramicidin Ointment USP). Do.
ANDA 61-523 Achromycin (tetracycline HCl) Diagnostic Susceptibility Wyeth-Ayerst Laboratories.
Powder, 20 mg.
ANDA 61-605 ETHRIL (Erythromycin Stearate Tablets USP). Bristol-Myers Squibb Co.
ANDA 62-224 Neomycin Sulfate Ointment USP. Do.
ANDA 62-305 Pediamycin Suspension and Pediamycin Oral Drops Abbot Laboratories, 100 Abbott Park Rd., D-491, AP6B-1SW,
(erythromycin ethylsuccinate for oral suspension). Abbott Park, IL 60064-6108.
ANDA 62-306 Erythromycin Ethylsuccinate Tablets, 200 mg. Do.
ANDA 62-334 Cefadroxil for Oral Suspension USP. Apothecon, Inc., A Bristol-Myers Squibb Co., P.O. Box 4500,
Princeton, NJ 08543-4500.
ANDA 62-390 Cifadroxil Tablets USP, 1 gram (g). Do.
ANDA 62-818 Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Fujisawa Healthcare, Inc., 3 Parkway North Center Deerfield,
Solution. IL 60015-2548.
ANDA 64-026 Tobramycin Sulfate Injection USP, 40 mg/mL. Apothecon, Inc.
ANDA 71-151 Bretylium Tosylate Injection. AstraZeneca, 725 Chesterbrook Blvd., Wayne, PA 19087-5677.
ANDA 71-153 Bretylium Tosylate Injection. Do.
ANDA 71-319 Naproxen Sodium Tablets USP. Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ
07207.
ANDA 74-360 Gemfibrozil Tablets USP, 600 mg. Do.
NDA 74-380 Metoprolol Tartrate Tablets USP, 50 mg and 100 mg. Do.
ANDA 74-658 Acyclovir Tablets USP, 400 and 800 mg. Lek Pharmaceutical and Chemical Co. d.d., c/o Lek USA, Inc.,
333 Sylvan Ave., Englewood Cliffs, NJ 07632.
ANDA 74-750 Acyclovir Capsules USP, 200 mg. Do.
ANDA 75-516 Serecon Eye Drops (pheniramine maleate and naphazoline HCl Optikem International, Inc., c/o Medvice Consulting, Inc.,
ophthalmic solution), 0.315%/0.02675%. 623 Glacier Dr., Grand Junction, CO 81503.
ANDA 80-321 Prednisone Tablets USP, 5 mg. Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd.
Charlotte, NC 28206.
ANDA 80-322 Prednisolone Tablets USP, 5 mg. Do.
ANDA 80-860 Vitamin A Capsules USP Bristol-Myers Squibb Co.
ANDA 83-807 Prednisolone Tablets USP, 20 mg. Vintage Pharmaceuticals, Inc.
ANDA 84-627 Quinidine Sulfate Tablets USP, 200 mg. Pharmavite Corp., P.O. Box 9606, Mission Hills, CA 91346-
9606.
ANDA 85-147 Quinidine Sulfate Tablets USP, 200 mg. Jones Pharma, Inc., 1945 Craig Rd., P.O. Box 46903, St.
Louis, MO 63146.
ANDA 85-150 Diphenhydramine HCl Capsules USP, 50 mg. Purepac Pharmaceutical Co.
ANDA 85-156 Diphenhydramine HCl Capsules USP, 25 mg. Do.
ANDA 85-665 Austaire (theophylline anhydrous) Tablets. Pfizer, Inc.
ANDA 86-454 AMITID Tablets (Amitriptyline HCl Tablets USP). Bristol-Myers Squibb Co.
ANDA 86-569 Theoclear L.A.-130 and Theoclear L.A.-260 (theophylline Schwarz Pharma, Inc., 5600 West County Line Rd., Mequon, WI
extended-release capsules, 130 mg and 260 mg). 53092.
ANDA 87-073 MD-76 (Diatrizoate Meglumine and Diatrizoate Sodium Mallinckrodt, Inc., 675 McDonnell Blvd., P.O. Box 5840, St.
Injection USP, 66%/10%). Louis, MO 63134.
ANDA 88-758 Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/ Mallinckrodt Chemical, Inc., P.O. Box P, 58 Pearl St.,
325 mg/40 mg. Hobart, NY 13788-0416.
ANDA 89-023 TRIAD (Butalbital, Acetaminophen, and Caffeine Capsules Do.
USP), 50 mg/325 mg/40 mg.
ANDA 89-102 FEMCET (Butalbital, Acetaminophen, and Caffeine Capsules Do.
USP), 50 mg/325 mg/40 mg.
ANDA 89-426 Dipyridamole Tablets USP, 50 mg. Purepac Pharmaceutical Co.
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[[Page 14985]]
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
April 19, 2000.
Dated: March 7, 2000.
Janet A. Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-6722 Filed 3-17-00; 8:45 am]
BILLING CODE 4160-01-F