[Federal Register Volume 61, Number 30 (Tuesday, February 13, 1996)]
[Notices]
[Pages 5562-5564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3077]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0029]
Reed & Carnrick Pharmaceuticals, et al.; Withdrawal of Approval
of 2 New Drug Applications and 67 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 2 new drug applications (NDA's) and 67 abbreviated new drug
applications (ANDA's). The holders of
[[Page 5563]]
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applications be withdrawn.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: March 14, 1996.
FOR FURTHER INFORMATION CONTACT: Lola 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 NDA's and 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.
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Application no. Drug-- Applicant
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6-309--......................... Kwell Lotion/Kwell Reed & Carnrick
Cream. Pharmaceuticals,
257 Cornelison
Ave., Jersey
City, NJ 07302-
3198.
10-718.......................... Kwell Shampoo..... Do.
70-021--........................ Metronidazole Halsey Drug Co.,
Tablets, USP, 250 Inc., 1827
milligrams (mg)--- Pacific St.,
-. Brooklyn, NY
11233.
70-205--........................ Diphenhydramine Barre-National,
Hydrochloride Inc., Johns
Cough Syrup, 12.5 Hopkins Bayview
mg/5 milliliters Research Campus,
(mL)--. 333 Cassell Dr.,
suite 3500,
Baltimore, MD
21224.
70-593--........................ Metronidazole Halsey Drug Co.,
Tablets, USP, 500 Inc.
mg.
70-635--........................ Indomethacin Do.
Capsules, USP, 50
mg.
70-782--........................ Indomethacin Do.
Capsules, USP, 25
mg.
70-906--........................ Metoclopramide Do.
Tablets, USP, 10
mg.
71-027--........................ Ibuprofen Tablets, Do.
USP, 200 mg.
71-028--........................ Ibuprofen Tablets, Do.
USP, 300 mg.
71-029--........................ Ibuprofen Tablets, Do.
USP, 400 mg.
71-030--........................ Ibuprofen Tablets, Do.
USP, 600 mg.
71-292--........................ Diphenhydramine L. Perrigo Co.,117
Hydrochloride Water St.,
Syrup, 12.5 mg/5 Allegan, MI
mL--. 49010.
71-434--........................ Lorazepam Tablets, Halsey Drug Co.,
USP, 0.5 mg. Inc.
71-435--........................ Lorazepam Tablets, Do.---
USP, 1 mg.
71-436--........................ Lorazepam Tablets, Do.---
USP, 2 mg.
71-753--........................ Methyldopa Do.---
Tablets, USP, 500
mg.
71-772--........................ Propranolol Warner Chilcott,
Hydrochloride and 201 Tabor Rd.,
Hydrochlorothiazi Morris Plains, NJ
de-Tablets, USP, 07950.
80 mg/ 25 mg-----.
72-137--........................ Ibuprofen Tablets, Halsey Drug Co.,
USP, 800 mg. Inc.---
72-646--........................ Diphenhydramine Silarx
Hydrochloride Pharmaceuticals,
Syrup, 12.5 mg/5 Inc., 19 West
mL----. St., P.O. Box
449, Spring
Valley, NY 10977.
80-015--........................ Propylthiouracil Halsey Drug Co.,
Tablets, USP, 50 Inc.
mg.
80-304--........................ Prednisolone Do.
Tablets, USP, 1
mg, 2.5 mg, and 5
mg.
80-498--........................ Rauwolfia Do.--- ---
Serpentina
Tablets, USP, 50
mg and 100 mg.
83-518--........................ Dienestrol Cream, Marion Merrill
USP, 0.01%-----. Dow, Inc., P.O.
Box 9627, Kansas
City, MO 64134-
0627.
83-538--........................ Propoxyphene Halsey Drug Co.,
Hydrochloride Inc.
Capsules, USP, 65
mg.
83-546--........................ Estradiol Valerate Steris
Injection, USP, Laboratories,
10 mg/mL---. Inc., 620 North
51st Ave.,
Phoenix, AZ 85043-
4705.
83-583--........................ Quinidine Sulfate Halsey Drug Co.,
Tablets, USP, 200 Inc.
mg.
83-598--........................ Folic Acid Do.
Tablets, USP, 1
mg.
83-871--........................ Acetaminophen and Do.--- ---
Codeine Phosphate
Tablets, USP, 300
mg/15 mg.
83-872--........................ Acetaminophen and Do.--- ---
Codeine Phosphate
Tablets, USP, 300
mg/30 mg.
83-891--........................ Hydrochlorothiazid Do.---
e Tablets, USP,
50 mg.
84-677--........................ Pentobarbital Do.---
Sodium Capsules,
USP, 100 mg.
84-685--........................ Chlordiazepoxide Do.---
Hydrochloride
Capsules, USP, 25
mg.
84-719--........................ Butabarbital Do.---
Sodium Tablets,
USP, 15 mg and 30
mg.
84-723--........................ Butabarbital Do.---
Sodium Elixir,
USP, 30 mg/5 mL.
85-067--........................ Hydrochlorothiazid Inwood
e Tablets, USP, Laboratories,
25 mg. Inc., 909 Third
Ave., New York,
NY 10022-4731.
85-148--........................ Theophylline Sandoz
Sodium Glycinate Pharmaceuticals
Tablets, USP, 150 Corp., 59 Route
mg. 10, East Hanover,
NJ 07936-1080.
85-211--........................ Diphenoxylate Halsey Drug Co.,
Hydrochloride and Inc. --- --- ---
Atropine Sulfate
Tablets, USP, 2.5
mg/0.025 mg.
85-339--........................ Chlordiazepoxide Do. ---
Hydrochloride
Capsules, USP, 10
mg.
85-340--........................ Chlordiazepoxide Do.
Hydrochloride
Capsules, USP, 5
mg.
85-409--........................ Aminophylline Vintage
Tablets, USP, 100 Pharmaceuticals,
mg. Inc., 3241
Woodpark Blvd.,
Charlotte, NC
28206.
85-410--........................ Aminophylline Do. ---
Tablets, USP, 200
mg.
85-922--........................ Amitriptyline Halsey Drug Co.,
Hydrochloride Inc. ---
Tablets, USP, 25
mg.
86-194--........................ Erythrityl Burroughs Wellcome
Tetranitrate Co., 3030
Tablets Cornwallis Rd.,
(chewable), 10 mg. P.O. Box 12700,
Research Triangle
Park, NC 27709-
2700.
86-504--........................ Hydrochlorothiazid Halsey Drug Co.,
e Tablets, USP, Inc. ---
25 mg.
86-549--........................ Acetaminophen and Do.
Codeine Phosphate
Tablets, USP, 300
mg/60 mg.
86-588--........................ Phenobarbital with Do.
Belladonna
Alkaloids Tablets.
[[Page 5564]]
86-652--........................ Phenobarbital with Solvay
Belladonna Pharmaceuticals,
Alkaloids Elixir. 901 Sawyer Rd.,
Marietta, GA
30062.
86-662--........................ Phenobarbital with Pharmaceutical
Belladonna Associates, P.O.
Alkaloids Elixir. Box 128,
Conestee, SC
29636.
87-136--........................ Hydrocortisone Westwood-Squibb
Cream, USP, 0.5%, Pharmaceuticals,
1%, and 2.5%. 100 Forest Ave.,
Buffalo, NY 14213-
1091.
87-200--........................ Aminophylline Fujisawa USA,
Injection USP, 25 Inc., 3 Parkway
mg/mL. North, 3d Floor,
Deerfield, IL
60015-2548.
87-480--........................ Prednisone Halsey Drug Co.,
Tablets, USP, 20 Inc. ---
mg.
87-802--........................ Dipyridamole Do. ---
Tablets, USP, 25
mg.
87-803--........................ Dipyridamole Do.---
Tablets, USP, 75
mg.
87-914--........................ Diphenhydramine Do.---
Hydrochloride
Capsules, USP, 50
mg.
88-048--........................ Fluocinolone Pharmaderm,
Acetonide Topical Division of
Solution, USP, Altana, Inc., 60
0.01%--- -. Baylis Rd.,
Melville, NY
11747.
88-192--........................ Triprolidine and Halsey Drug Co.,
Pseudoephedrine Inc.--- --- ---
Hydrochloride
Tablets, USP, 2.5
mg/60 mg.
88-466--........................ Dipyridamole Do.---
Tablets, USP, 50
mg.
88-662--........................ Chlorpropamide Do.---
Tablets, USP, 250
mg.
89-218--........................ Hydralazine Do.---
Hydrochloride
Tablets, USP, 10
mg.
89-321--........................ Chlorpropamide Do.---
Tablets, USP, 100
mg.
89-366--........................ Hydroxyzine Do.---
Hydrochloride
Tablets, USP, 10
mg.
89-396--........................ Hydroxyzine Do.---
Hydrochloride
Tablets, USP, 50
mg.
89-448--........................ Butalbital, Do.--- ---
Aspirin, and
Caffeine Tablets,
USP, 50 mg/325 mg/
40 mg.
89-465--........................ Leucovorin Calcium Burroughs Wellcome
for Injection, 50 Co.
mg/vial.
89-476--........................ Quinidine Halsey Drug Co.,
Gluconate Inc. --- ---
Extended-Release
Tablets, USP, 324
mg.
89-738--........................ Chlorthalidone Mutual
Tablets, USP, 25 Pharmaceutical
mg (Peach). Co., Inc., 1100
Orthodox St.,
Philadelphia, PA
19124-3131.
89-739--........................ Chlorthalidone Do.
Tablets, USP, 50
mg (Aqua).
89-833--........................ Leucovorin Calcium Burroughs Wellcome
for Injection, 25 Co.
mg/vial.
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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 above, and all amendments and
supplements thereto, is hereby withdrawn, effective March 14, 1996.
Dated: January 29, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-3077 Filed 2-12-96; 8:45 am]
BILLING CODE 4160-01-F