[Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
[Notices]
[Pages 13506-13508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7309]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES--
[Docket No. 96N-0095]
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of 49 New
Drug Applications, 9 Abbreviated Antibiotic Applications, and 36
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 49 new drug applications (NDA's), 9 abbreviated antibiotic
applications (AADA's), and 36 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that the approval of the applications be withdrawn.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: April 26, 1996.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-7), 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.
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Application no. Drug Applicant
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NDA 3-718....................... Synkayvite Tablets Hoffman-La Roche,
and Injection. Inc., 340
Kingsland St.,
Nutley, NJ 07110.
NDA 3-977....................... Theelin........... Parke-Davis, 2800
Plymouth Rd., Ann
Arbor, MI 48105.
NDA 6-071....................... Berocca Injectable Hoffman La Roche,
Inc.
NDA 6-128....................... Sopronol Ointment. Wyeth-Ayerst
Laboratories,
P.O. Box 8299,
Philadelphia, PA
19101-8299.
NDA 6-129....................... Sopronol Solution. Do.
NDA 6-130....................... Sopronol Powder... Do.
NDA 9-102....................... Antepar Tablets Burroughs Wellcome
and Syrup. Co., 3030
Cornwallis Rd.,
P.O. Box 12700,
Research Triangle
Park, NC 27709-
2700.
[[Page 13507]]
NDA 9-495....................... Marezine Injection Do.
NDA 9-519....................... Doriden Tablets... Rhone-Poulenc
Rorer
Pharmaceuticals,
Inc., 500 Arcola
Rd., Colegeville,
PA 19426-0107.
NDA 9-660....................... Noludar Tablets... Hoffman-La Roche,
Inc.
NDA 10-209...................... Meti-Derm Cream... Schering Corp.,
2000 Galloping
Hill Rd.,
Kenilworth NJ
07033.
NDA 10-773...................... Correctol Tablets. Schering-Plough
HealthCare
Products, 110
Allen Rd., P.O.
Box 276, Liberty
Corner, NJ 07938-
0276.
NDA 10-878...................... Visine Eye Drops.. Pfizer
Pharmaceuticals,
235 East 42d St.,
New York, NY
10017.
NDA 11-160...................... Thorexin Cough The Purdue
Medicine. Frederick Co.,
100 Connecticut
Ave., Norwalk, CT
06856.
NDA 11-296...................... Sunbath Protective Revlon, Research
Tanning Cream. Center, Inc., 121
Route 27, Edison,
NJ 08818.
NDA 11-297...................... Sunbath Protective Do.
Tanning Lotion.
NDA 11-657...................... Betaprone......... Forest
Pharmaceuticals,
Inc., 909 Third
Ave., New York NY
10022-4731.
NDA 11-844...................... Arthropan Liquid.. The Purdue
Frederick Co.
NDA 13-077...................... Xylocaine Astra
Suppositories. Pharmaceutical
Products, Inc.,
50 Otis St.,
Westborough, MA
01581.
NDA 13-094...................... Clysodrast Rhone-Poulenc
Evacuant Enema. Rorer
Pharmaceuticals,
Inc.
NDA 13-319...................... Iothalamate Sodium Mallinckrodt
80%. Medical Inc., 675
McDonnell Blvd.,
P.O. Box 5840,
St. Louis, MO
63134.
NDA 13-638...................... Indoklon.......... OHMEDA, Inc., 110
Allen Rd., P.O.
Box 804, Liberty
Corner, NJ 07938.
NDA 14-359...................... Meprobamate Halsey Drug Co.,
Tablets. Inc., 245 Old
Hook Rd.,
Westwood, NJ
07675.
NDA 14-740...................... Menrium Tablets... Hoffmann-La Roche,
Inc.
NDA 16-144...................... Ethamide Tablets.. Allergan, 2525
Dupont Dr., P.O.
Box 19534, Irvin,
CA 92713-9534.
NDA 16-219...................... Lemon Spree Colgate-Palmolive
Deodorant Soap. Co., 909 River
Rd., P.O. Box
1343, Piscataway,
NJ 08855-1343.
NDA 16-264...................... Palmolive Gold Do.
Antibacterial
Deodorant Soap.
NDA 16-278...................... Tackle Medicated Do.
Soap.
NDA 16-486...................... Antibacterial Do.
Deodorant Soap.
NDA 16-768...................... Estrovus Tablets.. Parke-Davis.
NDA 16-942...................... Halotex 1% Cream.. Westwood-Squibb
Pharmaceuticals,
100 Forest Ave.,
Buffalo, NY 14213-
1091.
NDA 17-129...................... Cholebrine........ Mallinckrodt
Medical, Inc.
NDA 17-486...................... Heparin Injection. Akorn, Inc., P.O.
Box 1220,
Decatur, IL
62525.
NDA 18-144...................... Centrax Capsules.. Parke-Davis
NDA 18-203...................... Liposyn 10%....... Abbott
Laboratories, D-
389, Bldg. AP30,
200 Abbott Park
Rd., Abbott Park,
IL 60064-3537.
NDA 18-223...................... Multivitamin Do.
Additive for
Injection.
NDA 18-288...................... Hypnomidate Janssen Research
Injection. Foundation, 1125
Trenton-
Harbourton Rd.,
P.O. Box 200,
Titusville, NJ
08560.
NDA 18-440...................... M.V.C. 9 + 3...... Fujusawa USA,
Inc., Parkway
North Center,
Three Parkway
North, Deerfield,
IL 60015-2548.
NDA 18-550...................... Rimadyl Tablets... Hoffmann-La Roche
Inc.
NDA 18-555...................... Yutopar Tablets... Astra USA, Inc.,
P.O. Box 4500,
Westborough, MA
01581-4500.
NDA 18-614...................... Liposyn 20%....... Abbott
Laboratories.
NDA 18-962...................... Manganese Chloride Do.
Injection.
NDA 19-185...................... Oxytocin in 5% Do.
Dextrose
Injection.
NDA 19-228...................... Magnesium Sulfate Fujisawa USA, Inc.
Injection.
NDA 19-271...................... Chromic Chloride Do.
Injection.
NDA 19-786...................... Lopressor OROS.... Ciba-Geigy Corp.,
556 Morris Ave.,
Summit NJ 07901-
1398.
NDA 50-502...................... Siseptin Injection Schering Corp.
NDA 50-523...................... Vira-A............ Parke-Davis.
NDA 50-532...................... Ilotycin Topical Lilly Research
Solution. Laboratories,
Lilly Corporate
Center,
Indianapolis IN
46285.
AADA 60-842..................... Penicillin V. Novo Nordisk
Potassium. Pharmaceuticals,
Inc., 100
Overlook Center,
suite 200,
Princeton, NJ
08540-7810.
AADA 61-864..................... Cephradine........ Apothecon Inc.,
P.O. Box 4500,
Princeton, NJ
08543-4500.
AADA 61-976..................... Cephradine........ Do.
AADA 62-047..................... Erythromycin KV Pharmaceutical
Ethylsuccinate Co., 2503 South
Oral Suspension. Hanley Rd., St.
Louis, MO 63144-
2555.
AADA 62-171..................... Chloramphenicol Optopics
Ophthalmic Laboratories
Solution. Corp., 32 Main
St., P.O. Box
210, Fairton, NJ
08320-0210.
[[Page 13508]]
AADA 62-413..................... Gentamicin Sulfate Abbott
in 9% Sodium Laboratories.
Chloride.
AADA 62-586..................... Erythromycin Do.
Lactobionate for
Injection.
AADA 62-871..................... Cephalexin Yoshitomi
Capsules. Pharmaceutical
Industries, c/o
Warner Chilcott
Laboratories, 182
Tabor Rd., Morris
Plains, NJ 07950.
AADA 62-872..................... Cephalex Capsules. Do.
ANDA 70-118..................... Diphenhydramine Morton Grove
Hydrochloride Pharmaceutical,
Cough Syrup. Inc., 6451 West
Main St., Morton
Grove, IL 60053.
ANDA 70-770..................... Dexbrompheniramine Geneva
Maleate and Pharmaceuticals,
Pseudoephedrine Inc., 2555 West
Sulfate Extended- Midway Blvd.,
Release Tablets. Broomfield, CO
80020.
ANDA 71-368..................... Propranolol Interpharm, Inc.,
Hydrochloride Three Fairchild
Tablets. Ave., Plainview,
NY 11803.
ANDA 71-369..................... Propranolol Do.
Hydrochloride
Tablets.
ANDA 71-370..................... Propranolol Do.
Hydrochloride
Tablets.
ANDA 71-371..................... Propranolol Do.
Hydrochloride
Tablets.
ANDA 71-819..................... Methylodpa and Novopharm, Ltd., c/
Hydrochlorothiazi o Granutec, Inc.,
de Tablets. 4409 Airport Dr.
NW., Wilson, NC
27896.
ANDA 71-820..................... Methyldopa and Do.
Hydrochlorothiazi
de Tablets.
ANDA 71-821..................... Methyldopa and Do.
Hydrochlorothiazi
de Tablets.
ANDA 71-822..................... Mehyldopa and Do.
Hydrochlorothiazi
de Tablets.
ANDA 74-106..................... Naproxen Sodium Hamilton
Tablets. Pharmaceuticals,
Ltd., c/o Syntex,
Inc., 3401
Hillview Ave.,
P.O. Box 10850,
Palo Alto, CA
94303.
ANDA 74-110..................... Naproxen Tablets.. Do.
ANDA 80-059..................... Aminosalicylate Wallace
and Laboratories,
Aminosalicylic 301B College Road
Acid Tablets, 846 East, Princeton,
milligrams (mg)/ NJ 08540.
112 mg.
ANDA 80-271..................... Methyltestosterone Rosemont
Sublingual Pharmaceutical
Tablets. Corp., 301 South
Cherokee St.,
Denver, CO 80223.
ANDA 80-384..................... Procaine Fujisawa USA, Inc.
Hydrochloride
Injection.
ANDA 83-376..................... Esterified Hoffmann-La Roche,
Estrogens Tablets. Inc.
ANDA 84-215..................... Esterified Do.
Estrogens Tablets.
ANDA 84-216..................... Esterified Do.
Estrogens Tablets.
ANDA 84-290..................... Potassium Chloride Fujisawa USA, Inc.
for Injection
Concentrate.
ANDA 85-266..................... Diphenoxylate MD
Hydrochloride and Pharmaceuticals,
Atropine Sulfate Inc., 3130 South
Tablets. Harbor Blvd.,
suite 320, Santa
Ana, CA 92704.
ANDA 85-303..................... Amithriptyline Roche Products,
Hydrochloride Inc., State Road
Tablets. 670, Km. 2.7,
P.O. Box 452,
Manati PR 00674-
0452.
ANDA 86-587..................... Phenobarbital with Halsey Drug Co.,
Belladonna Inc.
Alkaloids Elixir.
ANDA 87-723..................... Diatrizoate Berlex
Meglumine and Laboratories,
Diatrizoate Inc., 300
Sodium Injection. Fairfield Rd.,
Wayne NJ 07470-
7358.
ANDA 87-724..................... Diatrizoate Do.
Meglumine and
Diatrizoate
Sodium Injection.
ANDA 87-725..................... Diatrizoate Sodium Do.
Injection.
ANDA 87-726..................... Diatrizoate Do.
Meglumine
Injection.
ANDA 87-728..................... Diatrizoate Do.
Meglumine and
Diatrizoate
Sodium Solution.
ANDA 87-729..................... Diatrizoate Do.
Meglumine
Injection.
ANDA 87-731..................... Diatrizoate Do.
Meglumine
Injection.
ANDA 87-739..................... Diatrizoate Do.
Meglumine
Injection.
ANDA 87-768..................... Ipodate Sodium Do.
Capsules.
ANDA 87-787..................... Potassium Chloride Fujisawa USA, Inc.
for Injection
Concentrate.
ANDA 88-739..................... Promethazine Halsey Drug Co.,
Hydrochloride and Inc.
Codeine Phosphate
Syrup.
ANDA 88-868..................... Promethazine and Do.
Phenylephrine
Hydrochlorides
Syrup.
ANDA 88-870..................... Promethazine and Do.
Phenylephrine
Hydrochlorides
and Codeine
Phosphate Syrup.
ANDA 88-913..................... Promethazine Do.
Hydrochloride and
Dextromethorphan
Hydrobromide
Syrup.
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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 applications listed above, and all amendments and
supplements thereto, is hereby withdrawn, effective April 26, 1996.
Dated: March 7, 1996.
Janet Woodcock,
Center for Drug Evaluation and Research.
[FR Doc. 96-7309 Filed 3-26-96; 8:45 am]
BILLING CODE 4160-01-F