[Federal Register Volume 59, Number 107 (Monday, June 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13711]
[[Page Unknown]]
[Federal Register: June 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0195]
Adria Laboratories, et al.; Withdrawal of Approval of 15
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 15 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withdrawn.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: July 6, 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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17-959 Fluorouracil Adria Laboratories,
Injection,U.S.P., 50 P.O. Box 16529,
milligrams (mg)/milliliter Columbus, OH 43216-
(mL) 6529.
18-419 Furosemide Tablets, U.S.P., Warner Chilcott
20 mg, 40 mg, and 80 mg Laboratories, 201
Tabor Rd., Morris
Plain, NJ 07950.
18-420 Furosemide Injection, Do.
U.S.P., 10 mg/mL
18-670 Furosemide Injection, Wyeth-Ayerst
U.S.P., 10 mg/mL Laboratories, P.O.
Box 8299,
Philadelphia, PA
19101-1245.
18-690 Indomethacin Capsules, Chelsea
U.S.P., 25 mg and 50 mg Laboratories, Inc.,
896 Orlando Ave.,
West Hempstead, NY
11552.
19-106 Hydrocortisone Butyrate Galderma
Ointment 0.1% Laboratories, Inc.,
3000 Alta Mesa
Blvd., suite 300,
P.O. Box 331329,
Fort Worth, TX
76163.
72-398 Sulfamethoxazole and Barre-National,
Trimethoprim Oral Inc., 333 Cassell
Suspension, U.S.P., 200 mg/ Dr., suite 3500,
40 mg per 5 mL Baltimore, MD
21224.
85-191 Hydrocortisone Cream, Lemmon Co., 650
U.S.P., 1% Cathill Rd.,
Sellersville, PA
18960.
85-214 Sterile Hydrocortisone, Steris Laboratories,
Acetate Suspension, U.S.P., Inc., 620 North
50 mg/mL 51st Ave., Phoenix,
AZ 85043-4705.
86-001 Theophylline Syrup, 80-2 mg/ Barre-National, Inc.
15 mL
87-161 Dipyridamole Tablets, Chelsea
U.S.P., 75 mg Laboratories, Inc.
88-449 Fluocinolone Acetonide, Pharmafair, Inc.,
Topical Solution, U.S.P., 110 Kennedy Dr.,
0.01% Hauppauge, NY
11788.
88-475 Glycopyrrolate Injection, Fujisawa USA, Inc.,
U.S.P., 0.2 mg/mL Parkway North
Center, Three
Parkway North,
Deerfield, IL 60015-
2548.
88-606 Acetic Acid 2% and Aluminum Pharmafair, Inc.
Acetate Otic Solution
89-223 Theophylline Elixir, 80 mg/ Barre-National, Inc.
15 mL
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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 July 6, 1994.
Dated: May 24, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-13711 Filed 6-3-94; 8:45 am]
BILLING CODE 4160-01-F