[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Notices]
[Pages 36811-36812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17641]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0206]
Richmar International, Inc., et al.; Withdrawal of Approval of 2
Abbreviated Antibiotic Applications and 15 Abbreviated New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 2 abbreviated antibiotic applications (AADA's) and 15 abbreviated
new drug applications (ANDA'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withdrawn.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 17, 1995.
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 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.
------------------------------------------------------------------------
Application No. Drug----- Applicant
------------------------------------------------------------------------
AADA 60-446 -.......... Tetracycline Oral Richmar International,
Suspension, U.S.P. Inc., 1706 Birch Rd.,
McLean, VA 22101.
AADA 62-502--.......... Nystatin Vaginal Lemmon Co., 650
Tablets, U.S.P., Cathill Rd.,
100,000 units-. Sellersville, PA
18960.
ANDA 70-438---......... Propranolol Warner Chilcott, 201
Hydrochloride Tablets, Tabor Rd., Morris
U.S.P., 10-milligrams Plains, NJ 07950.
(mg).
ANDA 70-439-........... Propranolol Do.
Hydrochloride Tablets,
U.S.P., 20 mg.
ANDA 70-440---......... Propranolol Do.
Hydrochloride Tablets,
U.S.P., 40 mg.
ANDA 70-441---......... Propranolol Do.
Hydrochloride Tablets,
U.S.P., 60 mg.
[[Page 36812]]
ANDA 70-442---......... Propranolol Do.
Hydrochloride Tablets,
U.S.P., 80 mg.
ANDA 72-289---......... Sulfamethoxazole and Barre-National, Inc.,
Trimethoprim Oral 333 Cassell Dr.,
Suspension, U.S.P., suite 3500,
200 mg/40 mg per 5 Baltimore, MD 21224.
milliliters (mL).
ANDA 80-397---......... Prednisone Tablets, Lemmon Co.
U.S.P., 5 mg.
ANDA 80-398---......... Prednisolone Tablets, Do.
U.S.P.,-5 mg.
ANDA 84-389---......... Propantheline Bromide Do.
Tablets, U.S.P., 15 mg.
ANDA 86-490---......... Chlordiazepoxide Do.
Hydrochloride
Capsules, U.S.P., 10
mg.
ANDA 86-769---......... Lindane Lotion, U.S.P., Stiefel Laboratories,
1%--. Inc., Route 145, Oak
Hill, NY 12460.
ANDA 87-126---......... Phentermine Lemmon Co.
Hydrochloride
Capsules, U.S.P., 30
mg (Brown/Clear).
ANDA 87-777---......... Phentermine Do.
Hydrochloride
Capsules, U.S.P., 30
mg.
ANDA 87-940---......... Lindane Shampoo, Stiefel Laboratories,
U.S.P., 1%--. Inc.
ANDA 88-785---......... Hydroxyzine Barre-National, Inc.
Hydrochloride Syrup,
U.S.P., 10 mg/5 mL-.
------------------------------------------------------------------------
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 August 17, 1995.
Dated: July 5, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-17641 Filed 7-17-95; 8:45 am]
BILLING CODE 4160-01-F