[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Notices]
[Page 50628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24157]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0318]
Searle, et al.; Withdrawal of Approval of 17 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 17 new drug applications (NDA's). The holders of the NDA's notified
the agency in writing that the drug products were no longer being
marketed under the NDA and requested that the approval of the
applications be withdrawn.
EFFECTIVE DATE: September 29, 1995.
FOR FURTHER INFORMATION CONTACT: Nancy G. Maizel, Center for Drug
Evaluation and Research (HFD-53), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2623.
SUPPLEMENTARY INFORMATION: The holders of the NDA's listed below have
informed FDA that these drug products are no longer being marketed
under the NDA and have requested that FDA withdraw approval of the
applications. The applicants have also, by request, waived their
opportunity for a hearing.
------------------------------------------------------------------------
NDA No. Drug Applicant
------------------------------------------------------------------------
2-386........ Aminophyllin Tablets........ Searle, 4901 Searle Pkwy.,
Skokie, IL 60077
3-205........ Pantholin Tablets........... Lilly Research
Laboratories, Division of
Eli Lilly and Co., Lilly
Corporate Center,
Indianapolis, IN 46285.
6-917........ Gantrisin Injection......... Hoffmann-La Roche Inc.,
Roche Pharmaceuticals, 340
Kingsland St., Nutley, NJ
07110-1199.
8-867........ Rauwiloid Tablets........... 3M Pharmaceuticals, 3M
Center, St. Paul, MN 55144-
1000.
9-078........ Parsidol Tablets............ Parke-Davis Pharmaceutical
Research, 2800 Plymouth
Rd., Ann Arbor, MI 48105.
9-299........ Hyperloid Tablets........... Person & Covey Inc., P.O.
Box 25018, 616 Allen Ave.,
Glendale, CA 91221-5018.
11-045....... Milprem Tablets............. Wallace Laboratories,
Division of Carter-Wallace
Inc., 301B College Rd.
East, Princeton, NJ 08540.
11-110....... Actidil Tablets............. Burroughs Wellcome Co.,
3030 Cornwallis Rd., P.O.
Box 12700, Research
Triangle Park, NC 27709-
2700.
11-496....... Actidil Syrup............... Do.
11-535....... Equanil Meprobamate Wyeth-Ayerst Laboratories,
Suspension. P.O. Box 8299,
Philadelphia, PA 19101-
8299.
11-876....... Fedrazil Tablets............ Burroughs Wellcome Co.
17-528....... Uticort Lotion.............. Parke-Davis Pharmaceutical
Research.
17-917....... Duraquin Tablets............ Warner Chilcott
Laboratories, 201 Tabor
Rd., Morris Plains, NJ
07950.
18-375....... Turgex Bacteriostatic Skin Xttrium Laboratories Inc.,
Cleanser (Aerosol). 415 West Pershing Rd.,
Chicago, IL 60609.
19-055....... Turgex Bacteriostatic Skin Do.
Cleanser (Emulsion).
50-019....... Penbritin Ampicillin Drops.. Wyeth-Ayerst Laboratories.
50-355....... Coly-Mycin S Oral Suspension Parke-Davis Pharmaceutical
Research.
------------------------------------------------------------------------
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 NDA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective September 29, 1995.
Dated: September 2, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-24157 Filed 9-28-95; 8:45 am]
BILLING CODE 4160-01-P