[Federal Register Volume 59, Number 98 (Monday, May 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12555]
[[Page Unknown]]
[Federal Register: May 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0179]
Astra USA, Inc., et al.; Withdrawal of Approval of 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 62 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withdrawn.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: June 22, 1994.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, 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 below 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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ANDA no. Drug Applicant
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70-014................. Furosemide Injection, Astra USA, Inc., P.O.
U.S.P., 10 milligrams Box 4500,
(mg)/ milliliter (mL) Westborough, MA 01581-
(Ampules). 4500.
70-026................. Nitroglycerin International
Injection, U.S.P.. Medication Systems,
Ltd., 1886 Santa
Anita Ave., South El
Monte, CA 91733.
70-087................. Dopamine Hydrochloride Astra USA, Inc.
Injection, U.S.P., 40
mg/mL (Vials).
70-089................. Dopamine Hydrochloride Do.
Injection, U.S.P., 80
mg/mL (Ampules).
70-090................. Dopamine Hydrochloride Do.
Injection, U.S.P., 80
mg/mL (Vials).
70-093................. Dopamine Hydrochloride Do.
Injection, U.S.P., 160
mg/mL (Vials).
70-094................. Dopamine Hydrochloride Do.
Injection, U.S.P., 160
mg/mL (Ampules).
70-459................. Clonidine Hydrochloride Par Pharmaceutical,
Tablets, U.S.P., 0.3 Inc., One Ram Ridge
mg. Rd., Spring Valley,
NY 10977.
70-460................. Clonidine Hydrochloride Do.
Tablets, U.S.P., 0.2
mg.
70-461................. Clonidine Hydrochloride Do.
Tablets, U.S.P., 0.1
mg.
70-565................. Perphenazine and
Amitriptyline
Hydrochloride Tablets,
U.S.P., 2 mg/10 mg.
70-574................. Perphenazine and Do.
Amitriptyline
Hydrochloride Tablets,
U.S.P., 4 mg/50 mg.
70-595................. Perphenazine and Do.
Amitriptyline
Hydrochloride Tablets,
U.S.P., 4 mg/25 mg.
70-620................. Perphenazine and Do.
Amitriptyline
Hydrochloride Tablets,
U.S.P., 4 mg/10 mg.
70-621................. Perphenazine and Do.
Amitriptyline
Hydrochloride Tablets,
U.S.P., 2 mg/25 mg.
70-675................. Lorazepam Tablets, Do.
U.S.P., 0.5 mg.
70-676................. Lorazepam Tablets, Do.
U.S.P., 1 mg.
70-677................. Lorazepam Tablets, Do.
U.S.P., 2 mg.
71-152................. Bretylium Tosylate Astra USA, Inc.
Injection, 50 mg/mL.
71-815................. Sulfamethoxazole and Shionogi USA, Inc.,
Trimethoprim Tablets, 3848 Carson St.,
U.S.P., 400 mg/80 mg. suite 206, Torrance,
CA 90503.
71-816................. Sulfamethoxazole and Do.
Trimethoprim Tablets,
U.S.P., 800 mg/160 mg.
72-020................. Droperidol Injection, Astra USA, Inc.
U.S.P., 2.5 mg/mL
(Syringes).
72-028................. Fentanyl Citrate 0.05 Do.
mg/mL and Droperidol
2.5 mg/mL Injection
(Syringes).
72-071................. Nalbuphine Do.
Hydrochloride
Injection, 10 mg/mL
(Ampules).
72-072................. Nalbuphine Do.
Hydrochloride
Injection, 10 mg/mL
(Syringes).
72-074................. Nalbuphine Do.
Hydrochloride
Injection, 20 mg/mL
(Ampules).
72-075................. Nalbuphine Do.
Hydrochloride
Injection, 20 mg/mL
(Syringes).
72-082................. Naloxone Hydrochloride Do.
Injection, U.S.P.,
0.02 mg/mL,
Preservative Free
(Vials).
72-083................. Naloxone Hydrochloride Do.
Injection, U.S.P.,
0.02 mg/mL,
Preservative Free
(Syringes).
72-084................. Naloxone Hydrochloride Do.
Injection, U.S.P.,
0.02 mg/mL,
Preservative Free
(Ampules).
72-085................. Naloxone Hydrochloride Do.
Injection, U.S.P.,
0.02 mg/mL (Ampules).
72-087................. Naloxone Hydrochloride Do.
Injection, U.S.P., 0.4
mg/mL, Preservative
Free (Vials).
72-088................. Naloxone Hydrochloride Do.
Injection, U.S.P., 0.4
mg/mL, Preservative
Free (Syringes).
72-089................. Naloxone Hydrochloride Do.
Injection, U.S.P., 0.4
mg/mL (Ampules).
72-090................. Naloxone Hydrochloride Do.
Injection, U.S.P., 0.4
mg/mL, Preservative
Free (Ampules).
72-092................. Naloxone Hydrochloride Do.
Injection, U.S.P., 1
mg/mL (Syringes).
72-093................. Naloxone Hydrochloride
Do. Injection, U.S.P.,
1 mg/mL (Ampules).
72-106................. Propoxyphene Napsylate Halsey Drug Co., Inc.,
and Acetaminophen 1827 Pacific St.,
Tablets, U.S.P., 100 Brooklyn, NY 11233-
mg/650 mg. 3599.
72-212................. Pancuronium Bromide Astra USA, Inc.
Injection, 2 mg/mL
(Ampules).
72-275................. Propranolol Mylan Pharmaceuticals
Hydrochloride Tablets, Inc., 781 Chestnut
U.S.P., 60 mg. Ridge Rd., P.O. Box
4310, Morgantown, WV
26505-4310.
80-324................. Prednisolone Tablets, West-ward
U.S.P., 5 mg. Pharmaceutical Corp.,
465 Industrial Way
West, Eatontown, NJ
07724.
80-370................. Chlorpromazine Wyeth-Ayerst
Hydrochloride Laboratories, P.O.
Injection, U.S.P.. Box 8299,
Philadelphia, PA
19101-8299.
84-328................. Hydroflumethiazide with Do.
Reserpine.
85-121................. Atropine Sulfate and Do.
Meperidine
Hydrochloride
Injection.
85-641................. Dexamethasone Sodium Do.
Phosphate Injection,
U.S.P., 4 mg/mL.
86-165................. Cyproheptadine Chelsea Laboratories,
Hydrochloride Tablets, Inc., 896 Orlando
U.S.P., 4 mg. Ave., West Hempstead,
NY 11552.
86-332................. Meperidine International
Hydrochloride Medication Systems,
Injection, U.S.P., 10 Ltd.
mg/mL.
88-585................. Dicyclomine Pioneer
Hydrochloride Tablets, Pharmaceuticals,
U.S.P., 20 mg. Inc., 209 40th St.,
Irvington, NJ 07111.
88-731................. Methocarbamol Tablets, Do.
U.S.P., 500 mg.
88-949................. Folic Acid Tablets, Do.
U.S.P., 1 mg.
89-082................. Methocarbamol Tablets, Do.
U.S.P., 750 mg.
89-361................. Dicyclomine Do.
Hydrochloride
Capsules, U.S.P., 10
mg.
89-390................. Carisoprodol Tablets, Do.
U.S.P., 350 mg.
89-449................. Aluminum Hydroxide, 80 Pennex Products Co.,
mg and Magnesium Inc., Pennex Dr.,
Trisilicate, 20 mg. Verona, PA 15147.
89-592................. Chlorzoxazone Tablets,
U.S.P., 250 mg Inc.
Pioneer
Pharmaceuticals,.
89-781................. Meperidine Astra USA, Inc.
Hydrochloride
Injection, U.S.P., 25
mg/mL (Vials).
89-782................. Meperidine Do.
Hydrochloride
Injection, U.S.P., 50
mg/mL (Ampules).
89-783................. Meperidine Do.
Hydrochloride
Injection, U.S.P., 50
mg/mL (Vials).
89-785................. Meperidine Do.
Hydrochloride
Injection, U.S.P., 75
mg/mL (Vials).
89-786................. Meperidine Do.
Hydrochloride
Injection, U.S.P., 100
mg/mL (Ampules).
89-787................. Meperidine Do.
Hydrochloride
Injection, U.S.P., 100
mg/mL (Vials).
89-948................. Chlorzoxazone Tablets, Pioneer
U.S.P., 500 mg. Pharmaceuticals, Inc.
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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 ANDA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective June 22, 1994.
Dated: May 10, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-12555 Filed 5-20-94; 8:45 am]
BILLING CODE 4160-01-F