[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Notices]
[Pages 51457-51458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25198]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0340]
Lilly Research Laboratories, et al.; Withdrawal of Approval of 12
New Drug Applications, 8 Abbreviated Antibiotic Applications, and 23
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 12 new drug applications (NDA's), 8 abbreviated antibiotic
applications (AADA's), and 23 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that the approval of the applications be withdrawn.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: October 2, 1996.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1046.
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
------------------------------------------------------------------------
NDA 6-470...................... Calcium Gluceptate Lilly Research
Laboratories,
Lilly Corporate
Center,
Indianapolis, IN
46285.
NDA 8-826...................... Chlor-Trimeton Schering Corp.,
Injection. 2000 Galloping
Hill Rd.,
Kenilworth, NJ
07033.
NDA 9-585...................... Cort-Dome Bayer
(hydrocortisone, Pharmaceutical,
cream) Cream, \1/ 400 Morgan Ln.,
2\%, 1%. West Haven, CT
06516-4175.
NDA 11-284..................... Meprospan Wallace
(meprobamate) Laboratories,Half
Capsules, 200 Acre Rd., P.O.
milligrams (mg) Box 1001,
and 400 mg. Cranbury, NJ
08512-0181.
NDA 16-049..................... Innovar (fentanyl Janssen
citrate/ Pharmaceutica,
droperidol) for 1125 Trenton-
Injection. Harbourton Rd.,
P.O. Box 200
Titusville, NJ
08560-0200.
NDA 17-589..................... Solatene Hoffmann-LaRoche
(betacarotene) Inc., 340
Capsules. Kingsland St.,
Nutley, NJ 07110-
1199.
NDA 18-669..................... Niclocide Bayer
(niclosamide) Pharmaceutical.
Tablets.
NDA 18-806..................... Indomethacin Warner Chilcott
Capsules, 25 mg Laboratories, 200
and 50 mg. Plymouth Rd., Ann
Arbor, MI 28105.
NDA 18-830..................... Tambocor 3M
(flecainide Pharmaceuticals,
acetate) 50, 100, 3M Center, Bldg.
150 and 200 mg 270-3A-01, St.
Tablets. Paul, MN 55144-
1000.
NDA 19-329..................... Sodium Chloride Fujisawa USA,
Injection 23.4%. Inc., Parkway
North Center,
Three Parkway
North, Deerfield,
IL 60015-2548.
NDA 50-550..................... Moxan (moxalactam Lilly Research
disodium). Laboratories.
NDA 50-565..................... Coatin Hoffman-LaRoche,
(amdinocillin). Inc.
AADA 60-107.................... Sterile Lilly Research
Streptomycin Laboratories.
Sulfate.
[[Page 51458]]
AADA 60-384.................... Penicillin G Do.
Potassium for
Injection
(buffered).
AADA 60-385.................... Neomycin Sulfate Do.
Tablets, 500 mg
(eq. 350 mg base).
AADA 60-403.................... Penicillin G Do.
Potassium Tablets.
AADA 60-404.................... Streptomycin Do.
Sulfate Injection.
AADA 60-601.................... Penicillin G Do.
Potassium for
Injection.
AADA 60-687.................... Bacitracin Do.
Ophthalmic
Ointment, 500
units/gram.
AADA 61-742.................... Sterile Cefazolin Fujisawa
Sodium, vials. Pharmaceuticals
Co., Ltd., 1515
Fairway, Rydal
Park 181
Woodside,Rydal,
PA 19046-1664.
ANDA 70-591.................... Ibuprofen Tablets, Bayer Corp. 36
200 mg. Columbia Rd.,
Morristown, NJ
07962-1910.
ANDA 70-626.................... Ibuprofen Do.
Capsules, 200 mg.
ANDA 71-001.................... Ibuprofen Tablets, Do.
200 mg.
ANDA 71-002.................... Ibuprofen Do.
Capsules, 200 mg.
ANDA 71-508.................... Oxazepam Tablets, Warner Chilcott.
15 mg.
ANDA 71-767.................... Flurazepam Do.
Hydrochloride
Capsules, 15 mg.
ANDA 71-768.................... Flurazepam Do.
Hydrochloride
Capsules, 30 mg.
ANDA 72-138.................... Clonidine Do.
Hydrochloride
Tablets, 0.1 mg.
ANDA 72-139.................... Clonidine Do.
Hydrochloride
Tablets, 0.2 mg.
ANDA 72-140.................... Clonidine Do.
Hydrochloride
Tablets, 0.3 mg.
ANDA 80-419.................... Hydrocortisone H. R. Cenci
Acetate Cream, 1%. Laboratories,
Inc., P.O. Box
12524, Fresno, CA
93778-2524.
ANDA 83-632.................... Isoniazid Tablets, Halsey Drug Co.,
50 mg. Inc., 1827
Pacific St.,
Brooklyn, NY
11233-3599.
ANDA 85-501.................... Phentermine Lemmon Co., 650
Hydrochloride Cathill Rd.,
Capsules, 8 mg. Sellersville, PA
18960.
ANDA 85-502.................... Theophylline Forest
Andydrous Oral Laboratories,
Suspension, 100 Inc., 909 Third
mg/5 milliliters Ave., New York,
(mL). NY 10022-4731.
ANDA 85-924.................... Amitriptyline Halsey Drug Co.,
Hydrochloride Inc.
Tablets, 150 mg.
ANDA 86-240.................... Kenalog- Apothecon, P.O.
H Box 4500,
(Triamcinolone Princeton, NJ
Acetonide) Cream 08543-4500.
0.1%.
ANDA 87-941.................... Diphenhydramine H. R. Cenci
Hydrochloride Laboratories,
Elixir, 12.5 mg/5 Inc.
mL.
ANDA 88-303.................... Theophylline Do.
Elixir, 80 mg/15
mL.
ANDA 88-304.................... Diphenhydramine Do.
Hydrochloride
Elixir, 12.5 mg/5
mL.
ANDA 88-654.................... Theophylline Central
Extended-release Pharmaceuticals,
Capsules, 125 mg. Inc., 120 East
Third St., P.O.
Box 328, Seymour,
IN 47274-0328.
ANDA 89-013.................... Promethazine Plain H. R. Cenci
Syrup Laboratories,
(Promethazine Inc.
Hydrochloride),
6.25 mg/5 mL.
ANDA 89-458.................... Glutethimide Halsey Drug Co.,
Tablets,250 mg. Inc.
ANDA 89-568.................... Butalbital and Do.
Acetaminophen
Tablets, 50 mg/
325 mg.
------------------------------------------------------------------------
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 in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
October 2, 1996.
Dated: September 10, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-25198 Filed 9-30-96; 8:45 am]
BILLING CODE 4160-01-F
