[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: 94-12554]
[[Page Unknown]]
[Federal Register: May 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0181]
Fujisawa USA, Inc., et al.; Withdrawal of Approval of 22
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 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withdrawn.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 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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ANDA no. Drug Applicant
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70-223................ Sulfamethoxazole and Fujisawa USA, Inc.,
Trimethoprim Parkway North Center,
Concentrate for Three Parkway North,
Injection, USP, 80 Deerfield, IL 60015-
milligrams (mg)/ 2548.
milliliters (mL) and 16
mg/mL.
70-411................ Vincristine Sulfate Do.
Injection, USP, 1 mg/mL.
71-270................ Tolazamide Tablets, 250 Interpharm, Inc., 3
mg. Fairchild Ave.,
Plainview, NY 11803.
71-271................ Tolazamide Tablets, 500 Do.
mg.
71-299................ Sulfamethoxazole and Do.
Trimethoprim Tablets,
USP, 400 mg/80 mg.
71-300................ Sulfamethoxazole and Do.
Trimethoprim Tablets,
USP, 80 mg/160 mg.
71-621................ Cholestyramine Resin Parke-Davis, 2800
Bars (Caramel). Plymouth Rd., Ann
Arbor, MI 48105.
71-739................ Cholestyramine Resin Do.
Bars (Raspberry).
83-147................ Sterile Cortisone Steris
Acetate Suspension, Laboratories,Inc.,
USP, 25 mg/mL 50 mg/mL. P.O. Box 23160,
Pheonix, AZ 85063-
3160.
84-356................ Edetate Disodium Do.
Injection, USP, 150 mg/
mL.
85-028................ Hydrocortisone Ointment, Clay-Park Labs, Inc.,
USP, 1%. 1700 Bathgate Ave.,
Bronx, NY 10457.
85-663................ Hydrocortisone Lotion, Do.
USP, 1%.
86-466................ Aminophylline Oral Fisons Corp., 755
Solution, USP, 105 mg/5 Jefferson Rd., P.O.
mL. Box 1710, Rochester,
NY 14603-1710.
87-885................ Potassium Chloride for Fujisawa USA, Inc.
Injection Concentrate, Parkway North Center,
USP. Three Parkway North,
Deerfield, IL
87-912................ Triamcinolone Acetonide Pharmafair Inc., 110
Cream, USP, 0.1%. Kennedy Drive,
Hauppauge, NY 11788
87-921................ Triamcinolone Acetonide Do.
Cream, USP, 0.025%.
87-922................ Triamcinolone Acetonide Do.
Cream, USP, 0.5%.
88-032................ Sulfacetamide Sodium and Do.
Prednisolone Acetate
Ophthalmic Ointment,
USP, 0.125%.
88-165................ Prednisolone Sodium Do.
Phosphate Ophthalmic
Solution, USP, 1%.
88-385................ Sulfacetamide Sodium Do.
Ophthalmic Solution,
USP, 30%.
88-415................ Prednisolone Sodium Do.
Phosphate Ophthalmic
Solution, USP, 0.125%.
89-914................ Hydrocortisone Acetate Parke-Davis.
Cream, USP, 1%.
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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. 94-12554 Filed 5-20-94; 8:45 am]
BILLING CODE 4160-01-F
