[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4660]
[[Page Unknown]]
[Federal Register: March 2, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0044]
Riker Laboratories, Inc., et al.; Withdrawal of Approval of 91
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 91 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's and requested that the approval of the
applications be withdrawn.
EFFECTIVE DATE: April 1, 1994.
FOR FURTHER INFORMATION CONTACT: Nancy Maizel, Center for Drug
Evaluation and Research (HFD-53), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4320.
SUPPLEMENTARY INFORMATION: The holders of the NDA's listed in the table
below have informed FDA that these drug products are no longer being
marketed under the NDA's and have requested that FDA withdraw approval
of the applications. The applicants have also, by request, waived their
opportunity for a hearing.
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NDA No.
Drug Applicant
------------------------------------------------------------------------
0-607.. Ophthalmic Isophrin Solution. Riker Laboratories, Inc., 3M
Pharmaceuticals, 270-3A 3M
Center, St. Paul, MN 55144.
2-139.. Menadione and Proklo Tablets. Lilly Research Laboratories,
Division of Eli Lilly and Co.,
Lilly Corporate Center,
Indianapolis, IN 46285.
3-895.. Heparin Sodium Injection..... Lederle Laboratories, Division
of American Cyanamid Co., Pearl
River, NY 10965.
4-203.. Zylate Solution and Emulsion. The Upjohn Co., U.S.
Pharmaceutical Regulatory
Affairs, 7000 Portage Rd.,
Kalamazoo, MI 49001-0199.
5-725.. Kappadione Injection......... Lilly Research Laboratories.
5-969.. Racemic Desoxyephedrine HCl High Chemical Co., 1760 North
Tablets. Howard St., Philadelphia, PA
19122.
6-087.. Topocide Lotion.............. Lilly Research Laboratories.
6-303.. Thephorin Tablets, Lotion and Hoffmann-La Roche Inc., 340
Ointment. Kingsland St., Nutley, NJ 07110-
1199.
6-317.. Neotrizine Tablets and Lilly Research Laboratories.
Suspension, Co-Diazine
Suspension, Sulfonamides
Duplex Suspension, and
Sulfonamides Duplex Savoret
Tablets.
6-441.. Camoquin HCl Tablets......... Parke-Davis Pharmaceutical
Research, Division of Warner-
Lambert Co., 2800 Plymouth Rd.,
Ann Arbor, MI 48105.
6-798.. Berubigen Injection.......... The Upjohn Co.
6-946.. Aminosalicylic Acid and Merck Research Laboratories,
Sodium Aminosalicylate Merck & Co. Inc., West Point,
Powders. PA 19486.
7-037.. Berubigen Capsules........... The Upjohn Co.
7-245.. Aerolone Solution............ Lilly Research Laboratories.
7-384.. Cologel Liquid............... Do.
7-448.. Aminosalicylic Acid Tablets.. Do.
8-059.. Thiomerin and Thiomerin Wyeth-Ayerst Laboratories Inc.,
Sodium Injections. P.O. Box 8299, Philadelphia, PA
19101.
8-301.. Sunstick Ointment............ S.C. Johnson Wax, S.C. Johnson &
Son Inc., 1525 Howe St.,
Racine, WI 53403-5011.
8-576.. Teebaconin Tablets........... Palisades Pharmaceuticals Inc.,
219 County Rd., Tenafly, NJ
07670.
8-814.. Unitensen Injection.......... Wallace Laboratories, Division
of Carter-Wallace Inc., 301B
College Rd. East, Princeton, NJ
08540.
8-869.. Dicurin Procaine Injection... Lilly Research Laboratories.
8-915.. Clistin Tablets.............. R.W. Johnson Pharmaceutical
Research Institute, Welsh and
McKean Rds., Spring House, PA
19477-0776.
8-973.. Primaquine Tablets........... Parke-Davis Pharmaceutical
Research.
8-993.. Marezine Tablets............. Burroughs Wellcome Co., 3030
Cornwallis Rd., Research
Triangle Park, NC 27709.
9-217.. Unitensen Tablets............ Wallace Laboratories.
9-276.. Rauwolfia Serpentina and JMI-Canton Pharmaceuticals,
Hiwolfia Tablets. Inc., 119 Schroyer Ave. SW.,
Canton, OH 44702.
9-312.. Romilar Syrup................ Hoffmann-La Roche Inc.
9-344.. Histalog Injection........... Lilly Research Laboratories.
9-631.. Reserpine and Hiserpia JMI-Canton Pharmaceuticals, Inc.
Tablets.
9-645.. Reserpine and Serpivite Vitarine Pharmaceuticals Inc.,
Tablets. 227-15 North Conduit Ave.,
Springfield Gardens, NY 11413.
9-789.. Mylaxen Injection............ Wallace Laboratories.
9-980.. Camoprim Tablets............. Parke-Davis Pharmaceutical
Research.
10-289. Betadine Ointment............ The Purdue Frederick Co., 100
Connecticut Ave., Norwalk, CT
06850-3590.
10-290. Betadine Mouthwash........... Do.
10-573. Sodium Versenate Injection... Riker Laboratories, Inc.
10-586. Doxan Tablets................ Hoechst-Roussel Pharmaceuticals
Inc., Route 202-206 North,
Somerville, NJ 08876.
10-895. Norlutin Tablets............. Parke-Davis Pharmaceutical
Research.
11-047. Cardrase Tablets............. The Upjohn Co.
11-267. Halodrin Tablets............. Do.
11-294. Trilafon Syrup............... Schering Corp., Galloping Hill
Rd., Kenilworth, NJ 07033.
11-361. Trilafon Tablets............. Do.
11-429. Betadine Aerosol Spray....... The Purdue Frederick Co.
11-491. Vesprin Suspension and Apothecon, Bristol-Myers Squibb
Emulsion. Co., P.O. Box 4500, Princeton,
NJ 08543-4500.
11-914. Virac Surgical and Virac Rex Sherwood Medical, 1915 Olive
Solutions. St., St. Louis, MO 63103-1642.
11-945. Hispril Capsules............. SmithKline Beecham
Pharmaceuticals, Four Falls
Corporate Center, Route 23 and
Woodmont Ave., P.O. Box 1510,
King of Prussia, PA 19406.
12-033. Sevinol Tablets.............. Schering Corp.
12-126. ULO (chlophedianol Riker Laboratories Inc.
hydrochloride) Syrup.
12-155. Rela Tablets................. Schering Corp.
12-273. Betadine Surgical Scrub The Purdue Frederick Co.
Liquid.
12-307. SunDare Clear Lotion......... S.C. Johnson Wax.
12-728. Ortho-Novum 10 milligrams R.W. Johnson Pharmaceutical
(mg), Ortho-Novum 2 mg-20, Research Institute.
Ortho-Novum 2 mg-21, and
Ortho-Novum 1/50-20 Tablets
(those portions of NDA only).
12-751. Head and Shoulders Shampoo... The Procter & Gamble Co., Sharon
Woods Technical Center, 11511
Reed Hartman Hwy., Cincinnati,
OH 45241-9974.
12-936. Drolban Injection............ Lilly Research Laboratories.
13-141. Sonilyn Tablets.............. Wallace Laboratories.
13-376. Propoquin Dihydrochloride Parke-Davis Pharmaceutical
Injection. Research.
13-554. Norlestrin 2.5-mg Tablets.... Do.
14-360. Head and Shoulders Shampoo... The Procter & Gamble Co.
14-968. Dristan Sustained Action Whitehall Laboratories, 685
Capsules. Third Ave., New York, NY 10017-
4076.
16-242. Norlestrin Tablets........... Parke-Davis Pharmaceutical
Research.
16-393. Head and Shoulders Shampoo... The Procter & Gamble Co.
16-605. Head and Shoulders Lotion Do.
Shampoo.
16-723. Norlestrin 28 1/50 Tablets... Parke-Davis Pharmaceutical
Research.
16-735. Surgidine Solution........... Wallace Laboratories.
16-766. Norlestrin FE 1/50 Tablets... Parke-Davis Pharmaceutical
Research.
16-813. Vapo-Iso Inhalant............ Fisons Pharmaceuticals, Fisons
Corp., Jefferson Rd., P.O. Box
1710, Rochester, NY 14603.
17-033. Heparin Sodium and Sodium Lyphomed Inc., 2045 North
Heparin Injections. Cornell Ave., Melrose Park, IL
60160-1002.
17-079. Haldol Solutab Tablets....... R.W. Johnson Pharmaceutical
Research Institute.
17-346. Heparin Sodium and Heparin Parke-Davis Pharmaceutical
Lock Flush Injections. Research.
17-366. Mucomyst with Isoproterenol Bristol-Myers Squibb Co.,
Solution. Bristol-Myers U.S.
Pharmaceutical Group, 2400 West
Lloyd Expressway, Evansville,
IN 47721-0001.
17-374. Dormate Tablets.............. Wallace Laboratories.
17-415. Centrax Tablets and Verstran Parke-Davis Pharmaceutical
Capsules. Research.
17-485. Vosol Otic Solution.......... Wallace Laboratories.
17-718. Heprinar Injection........... Armour Pharmaceutical Co., A
Company of Rorer Group Inc.,
500 Virginia Dr., Fort
Washington, PA 19034.
18-232. Somophyllin Enema............ Fisons Pharmaceuticals.
18-296. Tymtran Injection............ Adria Laboratories, P.O. Box
16529, Columbus, OH 43216-6529.
18-497. Sodium Chloride 0.45% Baxter Healthcare Corp.,
Solution. Parenterals Division, Route 120
and Wilson Rd., Round Lake, IL
60073.
18-522. Glycine 1.5% Solution........ Do.
19-130. Heparin Sodium 1,000 Units in Kendall McGaw Laboratories Inc.,
Dextrose 5%, Heparin Sodium P.O. Box 25080, Santa Ana, CA
5,000 Units in Dextrose 5%, 92799-5080.
and Heparin Sodium 2,000
Units in Dextrose 5%
Injections.
19-326. Synovalyte Solution in Baxter Healthcare Corp.
Plastic Container.
19-412. Head and Shoulders The Proctor and Gamble Co.
Conditioner Lotion.
19-490. Curity Surgical Scrub Brush- Becton Dickinson AcuteCare, 9450
Sponge. South State St., Sandy, UT
84070-3234.
50-046. Veracillin Capsules.......... Wyeth-Ayerst Laboratories.
50-056. Principen '250' and Principen Apothecon.
'500' Capsules.
50-183. Chloromycetin Cream.......... Parke-Davis Pharmaceutical
Research.
50-203. Chloromyxin Ophthalmic Do.
Ointment.
50-289. Coly-Mycin S Ophthalmic Drops Do.
50-374. Neo-Cortef Lotion............ The Upjohn Co.
50-450. Mutamycin Powder for Bristol-Myers Squibb Co.
Injection.
50-488. Principen with Probenecid Apothecon.
Capsules.
50-495. Amikin Injection............. Do.
------------------------------------------------------------------------
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 of the 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 April 1, 1994.
Dated: February 3, 1994.
Gerald F. Meyer,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-4660 Filed 3-1-94; 8:45 am]
BILLING CODE 4160-01-P
