[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37653-37654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17923]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0207]
Owen/Galderma, et al.; Withdrawal of Approval of 1 New Drug
Application, 23 Abbreviated New Drug Applications, and 5 Abbreviated
Antibiotic Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 1 new drug application (NDA), 23 abbreviated new drug applications
(ANDA's), and 5 abbreviated antibiotic applications (AADA'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of the applications be withdrawn.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: August 21, 1995.
FOR FURTHER INFORMATION CONTACT: Lola 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 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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Appication no. Drug Applicant
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ANDA 18-795..................... Hydrocortisone Owen/Galderma,
Butyrate Cream, 6201 South
0.1%. Freeway, P.O. Box
6600, Forth
Worth, TX 76115.
NDA 50-610...................... Erythromycin Paddock
U.S.P. for Laboratories,
Extemporaneous Inc., P.O. Box
Compounding of 27286,
Topical Solutions. Minneapolis, MN
55427.
AADA 62-656..................... Nystatin and Pharmafair, Inc.,
Triamcinolone 8500 Hidden River
Acetonide Pkwy., Tampa, FL
Ointment, U.S.P-. 33637.
AADA 62-657..................... Nystatin and Do.
Triamcinolone
Acetonide Cream,
U.S.P.
AADA 63-183..................... Cefamandole Richmar
Naftate for International,
Injection, Inc., 1706 Birch
U.S.P., bulk. Rd., McLean, VA
22101.
AADA 63-184..................... Sterile Do.
Cefamandole
Naftate, U.S.P.
AADA 64-018..................... Amikacin Sulfate, Do.
U.S.P.,
nonsterile bulk.
ANDA 70-077..................... Nitroglycerin Fujisawa USA,
Injection, Inc., 3 Parkway
U.S.P., 5 North, 3rd floor,
milligrams (mg)/ Deerfield, IL
milliliter (mL). 60015-2548.
ANDA 70-524..................... Dephenhydramine The Procter and
Hydrochloride Gamble Co.,
Syrup, 12.5 mg/5 Sharon Woods
mL. Technical Center,
11450 Grooms Rd.,
Cincinnati, OH
45242-1434.
ANDA 70-648..................... Naloxone Fujisawa USA, Inc.
Hydrochloride
Injection,
U.S.P., 0.02 mg/
mL.
ANDA 70-649..................... Naloxone Do.
Hydrochloride
Injection,
U.S.P., 0.04 mg/
mL.
ANDA 72-191..................... Clofibrate Geneva
Capsules, U.S.P., Pharmaceuticals,
500 mg. Inc., 2555 West
Midway Blvd.,
P.O. Box 446,
Broomfield, CO
80038-0446.
ANDA 83-951..................... Acetaminophen and Burroghs Wellcome
Codeine Phosphate Co., 3030
Tablets, U.S.P., Cornwallis Rd.,
300 mg/30 mg and P.O. Box 12700,
300 mg/60 mg. Research Triangle
Park, NC 27709-
2700.
ANDA 83-963..................... Quinidine Sulfate Vintage
Tablets, U.S.P., Pharmaceuticals,
200 mg. Inc., 3241
Woodpark Blvd.,
Charlotte, NC
28206.
ANDA 84-301..................... Hydralazine Lemmon Co., Inc.,
Hydrochloride 650 Cathill Rd.,
Tablets, U.S.P., Sellersville, PA
25 mg. 18960.
ANDA 84-969..................... Hydrocortisone Clay-Park Labs.,
Ointment, U.S.P., 1700 Bathgate
0.5%. Ave., Bronx, NY
10457.
ANDA 84-970..................... Hydrocortisone Do.
Cream, U.S.P.,
0.5%.
ANDA 85-026..................... Hydrocortisone Do.
Cream, U.S.P., 1%.
ANDA 85-500..................... Phentermine Lemmon Co.
Hydrochloride
Tablets, U.S.P.,
8 mg.
ANDA 85-662..................... Hydrocortisone Clay-Park Labs.
Lotion, U.S.P.,
0.5%.
ANDA 86-095..................... Chlorpheniramine Steris
Maleate Laboratories,
Injection, Inc., P.O. Box
U.S.P., 100 mg/mL. 23160, Phoenix,
AZ 85063-3160.
ANDA 86-606..................... Aminophylline King
Injection, Pharmaceuticals,
U.S.P., 25 mg/mL. Inc., 501 Fifth
St., Bristol, TN
37620.
ANDA 88-123..................... Isosorbide Zeneca
Dinitrate Pharmaceuticals,
Tablets, U.S.P., 1800 Concord
10 mg, sublingual. Pike, P.O. Box
15437,
Wilmington, DE
19850-5437.
ANDA 88-407..................... Aminophylline Fujisawa USA, Inc.
Injection,
U.S.P., 25 mg/mL,
100 mL vials.
ANDA 88-448..................... Dexamethasone Do.
Sodium Phosphate
Injection,
U.S.P., 4 mg/mL,
vials.
ANDA 88-645..................... Dicyclomine Lemmon Co.
Hydrochloride
Capsules, U.S.P.,
20 mg.
[[Page 37654]]
ANDA 89-222..................... Hydralazine Halsey Drug Co.,
Hydrochloride Inc., 1827
Tablets, U.S.P., Pacific St.,
50 mg. Brooklyn, NY
11233.
ANDA 89-252..................... Isoetharine Dey Laboratories,
Hydrochloride 2751 Napa Valley
Inhalation Corporate Dr.,
Solution, U.S.P., Napa, CA 94558.
1%.
ANDA 89-554..................... Hydrocodone Halsey Drug Co.,
Bitartrate and Inc.
Acetaminophen
Tablets, U.S.P.,
5 mg/500 mg.
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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 and supplements thereto, is hereby
withdrawn, effective August 21, 1995.
Dated: July 5, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-17923 Filed 7-20-95; 8:45 am]
BILLING CODE 4160-01-F