[Federal Register Volume 59, Number 78 (Friday, April 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9700]
[[Page Unknown]]
[Federal Register: April 22, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0143]
Parke-Davis Pharmaceutical Research, et al.; Withdrawal of
Approval of 31 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 31 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withdrawn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: May 23, 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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70-872 Nitroglycerin Injection, USP, Parke-Davis Pharmaceutical
100 milligrams (mg) in 10 Research, 2800 Plymouth Rd.,
milliliter (mL) Ampoules. Ann Arbor, MI 48105.
80-279 Prednisone Tablets, USP, 5 mg. Inwood Laboratories, Inc.,
150 East 58th St., New York,
NY 10155.
80-314 Chlorpromazine Hydrochloride H. Reisman Corp., 337 Crane
Tablets, USP. St., Orange, NJ 07051.
80-320 Prednisone Tablets, USP, 5 mg. Heather Drug Co., Inc., c/o
Lachman Consultant Services,
Inc., 1600 Stewart Ave.,
Westbury, NY 11590.
80-328 Prednisone Tablets, USP, 1 mg. Inwood Laboratories, Inc. 150
East 58th St., New York, NY
10155.
80-748 Prednisolone Tablets, USP..... Do.
80-784 Folic Acid Tablets, USP, 1 mg. Purepac Pharmaceutical Co.,
200 Elmora Ave., Elizabeth,
NJ 07207.
80-839 Methyltestosterone Tablets, 10 Inwood Laboratories, Inc. 150
mg. East 58th St., New York, NY
10155.
80-973 Methyltestosterone Tablets, 25 Do.
mg.
83-270 Pentobarbital Sodium Elkins-Sinn, Inc., 2
Injection, Inc.. Esterbrook Lane, Cherry
Hill, NJ 08003-4099.
84-417 Prednisone Tablets, USP, 20 mg Heather Drug Co., Inc. c/o
Lachman Consultant Services,
Inc., 1600 Stewart Ave.,
Westbury, NY 11590.
84-698 Hydrocortisone Gel, USP, 1%... Galderma Laboratories, Inc.,
3000 Alta Mesa Blvd., suite
300, P.O. Box 331329, Fort
Worth, TX 76163.
84-776 Hydrochlorothiazide Tablets, Inwood Laboratories, Inc. 150
50 mg. East 58th St., New York, NY
10155.
85-507 Phendimetrazine Tartrate Lemmon Co., 650 Cathill Rd.,
Capsules, USP, 35 mg. Sellersville, PA 18960.
85-983 Theophylline Extended-Release Whitby Pharmaceuticals Inc.,
Capsules, USP, 260 mg. 2801 Reserve St., P.O. Box
27426, Richmond, VA 23261-
7426.
86-678 Cyproheptadine Hydrochloride Mylan Pharmaceuticals Inc.,
Tablets, USP, 4 mg. P.O. Box 4310, 781 Chestnut
Ridge Rd., Morgantown, WV
26505-4310.
87-196 Fluoxymesterone Tablets, USP, ICN Pharmaceuticals, Inc.,
10 mg. ICN Plaza, 3300 Hyland Ave.,
Costa Mesa, CA 92626.
87-222 Methyltestosterone Tablets, Do.
USP, 5 mg.
87-679 Theophylline Elixir, 80 mg/15 Cenci Products, H.R. Cenci
mL. Laboratories, P.O. Box
12524, Fresno, CA 93778-
2524.
87-781 Methoxsalen Capsules, USP, 10 ICN Pharmaceuticals, Inc.,
mg. ICN Plaza, 3300 Hyland Ave.,
Costa Mesa, CA 92626.
87-854 Theophylline Extended-Release Whitby Pharmaceuticals Inc.,
Capsules, USP. 2801 Reserve St., P.O. Box
27426, Richmond, VA 23261-
7426.
87-931 Lidocaine Hydrochloride USP, The Kendall Co., Topical
4%. Solution, 15 Hampshire St.,
Mansfield, MA 02048.
87-961 Hydrocodone Bitartrate 5 mg Forest Laboratories, Inc.,
Acetaminophen 500 mg Capsules. 150 East 58th St., New York,
NY 10155-0181.
87-980 Lidocaine Hydrochloride Abbott Laboratories, One
Injection, USP, 10%. Abbott Park Rd., Abbott
Park, IL 60064-3500.
88-221 Fluoxymesterone Tablets 10 mg, ICN Pharmaceuticals, Inc. ICN
Plaza, 3300 Hyland Ave.,
Costa Mesa, CA 92626.
88-283 Triprolidine Hydrochloride Cenci Products H.R. Cenci
1.25 mg/5 mL and Laboratories,. P.O. Box
Pseudoephedrine Hydrochloride 12524, Fresno, CA 93778-
30 mg/5 mL Syrup. 2424.
88-842 Hydrocortisone Ointment USP, Pharmaderm, Baylis Rd.,
1%,. Melville, NY 11747.
88-923 Hydrochlorothiazide USP, 50 mg Lemmon Co., 650 Cathill Rd.,
Tablets. Sellersville, PA 18960.
88-924 Hydrochlorothiazide Tablets, Do.
USP, 25 mg.
89-019 Reserpine Tablets, USP, 0.25 Do.
mg.
89-020 Reserpine Tablets, USP, 0.1 mg Do.
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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 May 23, 1994.
Dated: April 11, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-9700 Filed 4-21-94; 8:45 am]
BILLING CODE 4160-01-F