[Federal Register Volume 64, Number 183 (Wednesday, September 22, 1999)]
[Notices]
[Pages 51325-51326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24595]
[[Page 51325]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-4004]
Wallace Laboratories et al.; Withdrawal of Approval of 18 New
Drug Applications and 44 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 18 new drug applications (NDA's) and 44 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requested that the approval of the applications be withdrawn.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: September 22, 1999.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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 4-253 Davitamin Tablets Wallace Laboratories, 301B College Rd.,
East, Princeton, NJ 08540.
NDA 5-932 5% Aminosol Abbott Laboratories, One Abbott Park Rd.,
Abbott Park, IL 60064-3500.
NDA 6-668 Redisol (cyanocobalamin) Tablets and Merck & Co., Inc., 5 Sentry Pkwy., East
Injection. (BLA-10), Blue Bell, PA 19422.
NDA 7-842 Flaxedil (gallamine triethiodide Kendall Healthcare Products Co., 15
injection), 20 milligrams (mg)/milliter Hampshire St., Mansfield, MA 02048.
(mL).
NDA 9-295 Vibazine (buclizine hydrochloride) Tablets. Pfizer Pharmaceuticals, 235 East 42d St.,
New York, NY 10017-5755.
NDA 10-460 Preludin (phenmetrazine hydrocholoride) Boehringer Ingelheim Pharmaceuticals, Inc.,
Tablets. 900 Ridgebury Rd., P.O. Box 368,
Ridgefield, CT 06877.
NDA 10-639 Hydeltrasol (prednisolone sodium phosphate Merck & Co., Inc., P.O. Box 4, BLA-20, West
ophthalmic solution) Sterile Ophthalmic Point, PA 19486.
Solution.
NDA 11-612 Daricon (oxyphenylcyclamine hydrochloride) Pfizer Pharmaceuticals.
Tablets.
NDA 11-752 Preludin (phenmetrazine hydrochloride) Boehringer Ingelheim Pharmaceuticals, Inc.
Endurets.
NDA 17-497 Synthetic Calcimar (calcitonin-salmon) for Rhone-Poulenc Rorer Pharmaceuticals, Inc.,
Injection. 500 Arcola Rd.,P.O. Box 1200,
Collegeville, PA 19426-0107.
NDA 18-208 Pfi-Lith (lithium carbonate) Capsules. Pfizer Pharmaceuticals.
NDA 18-237 Calciparine (heparin calcium) Injection. Sanofi Pharmaceuticals, Inc., 90 Park Ave.,
New York, NY 10019.
NDA 18-342 Wellcovorin (leucovorin calcium) Tablets. Glaxo Wellcome, Inc., 5 Moore Dr., P.O. Box
13398, Research Triangle Park, NC 27709.
NDA 18-499 Lactated Ringer's and Dextrose Injection Miles, Inc., Pharmaceutical Div., 4th and
USP. Parker Sts., P.O. Box 1986, Berkeley, CA
94701.
NDA 18-933 MVI-12 Powder Astra USA, Inc., P.O. Box 4500,
Westborough, MA 01581-4500.
NDA 19-498 Parathar (teriparatide acetate) for Rhone-Poulenc Rorer Pharmaceuticals, Inc.
Injection.
NDA 20-841 Lotemax (loteprednol etabonate ophthalmic Pharmos Corp., c/o Bausch & Lomb
suspension), 0.5% Ophthalmic Suspension. Pharmaceuticals, Inc., 8500 Hidden River
Pkwy., Tampa, FL 33637.
NDA 50-762 Trovan/Zithromax Compliance Pak Pfizer Pharmaceuticals.
(trovafloxacin mesylate/azithromycin for
oral suspension).
ANDA 60-082 Tetracyn (tetracycline) Capsules. Pfizer, Inc., 235 East 42d St., New York,
NY 10017-5755.
ANDA 60-290 Tetracycline Hydro-chloride Capsules USP, Purepac Pharmaceutical Co., 200 Elmora
250 mg and 500mg. Ave., Elizabeth, NY 07207.
ANDA 60-458 Terramycin (oxytetracyclinewith polymyxin B Pfizer, Inc.
sulfate) Topical Powder with Polymyxin B
Sulfate.
ANDA 60-586 Terramycin (oxytetracycline) IV. Do.
ANDA 60-595 Terramycin (oxytetracycline) Syrup. Do.
ANDA 60-731 Bacitracin Neomycin-Polymyxin with Altana, Inc., 60 Baylis Rd., Melville, NY
Hydrocortisone Acetate Ophthalmic Ointment 11747.
1%.
ANDA 61-009 Terra-Poly (oxytetracycline, polymyxin B Pfizer, Inc.
sulfate) Vaginal Tablets.
ANDA 61-010 Terramycin (oxytetracycline) Tablets. Do.
ANDA 61-277 Penicillin G Potassium Tablets for Oral Teva Pharmaceuticals, USA, 1510 Delp Dr.,
Solution USP. Kulpsville, PA 19443.
ANDA 61-841 Terramycin (oxytetracycline) with Polymyxin Pfizer, Inc.
B Sulfate Otic Ointment.
ANDA 62-288 Gentamicin Sulfate Injection, 40 mg/mL. Bristol Laboratories, P.O. Box 4755,
Syracuse, NY 13221-4755.
ANDA 62-289 Gentamicin Sulfate Injection USP. King Pharmaceuticals, Inc., 501 Fifth St.,
Bristol, TN 37620.
ANDA 62-598 Neomycin Sulfate-Triamcinolone Acetonide Savage Laboratories, Inc., Division of
Cream. Altana Inc., 60 Baylis Rd., Melville, NY
11747.
ANDA 62-607 Neomycin Sulfate-Triamcinolone Acetonide Pharmaderm, Division of Altana, Inc., 60
Ointment. Baylis Rd.,Melville, NY 11747.
[[Page 51326]]
ANDA 70-656 Dopamine Hydrochloride Injection USP, 40 mg/ Abbott Laboratories.
mL.
ANDA 70-657 Dopamine Hydrochloride Injection USP, 80 mg/ Do.
mL.
ANDA 73-611 Diphenhydramine Hydrochloride Cough Syrup, Cumberland-Swan, Inc., 1 Swan Dr., Smyrna,
12.5 mg/5 mL. TN 37167.
ANDA 80-195 Potassium Chloride Injection. Miles, Inc.
ANDA 80-211 Prednisolone Tablets, 5 mg. Private Formulations, Inc., 460 Plainfield
Ave., Edison, NJ 08818.
ANDA 80-830 Vitamin A Capsules USP, 15 mg. Del Ray Labs, Inc., 22-20th Ave., NW.,
Birmingham, AL 35215.
ANDA 83-021 Sulfacetamide Sodium Ophthalmic Solution AKORN, Inc., 1222 West Grand, Decatur, IL
USP, 10%, 15%, and 30%. 62526.
ANDA 83-256 Alcohol in Dextrose Injection USP, 5%/5%. Baxter Healthcare Corp., Rte. 120 and
Wilson Rd., Round Lake, IL 60073-0490.
ANDA 84-652 Chlorotrianisene Capsules USP, 12 mg. Banner Pharmacaps, 200730 Dearborn St.,
P.O. Box 2157, Chatsworth, CA 91313-2157.
ANDA 84-708 Triamcinolone Tablets, 2 mg. Roxane Laboratories, Inc., P.O. Box 16532,
Columbus, OH 43216-6532.
ANDA 84-775 Triamcinolone Tablets, 4 mg. Teva Pharmaceuticals, USA.
ANDA 85-697 Phendimetrazine Tartrate Tablets, 35 mg Private Formulations, Inc.
(pink).
ANDA 85-914 Phendimetrazine Tartrate Tablets, 35mg. Manufacturing Chemist, Inc., c/o Integrity
Pharmaceutical Corp., 5767 Thunderbird
Rd., Indianapolis, IN 46236.
ANDA 86-192 Hydrochlorothiazide Tablets, 25 mg and 50 M. M. Mast & Co., 4152 Ruple Rd.,
mg. Cleveland, OH 44121.
ANDA 86-217 Chlordiazepoxide Capsules, 10 mg. Do.
ANDA 86-259 Trichlormethiazide, 4 mg. Do.
ANDA 86-521 Dextroamphetamine Sulfate Tablets, 5 mg. Do.
ANDA 86-523 Phenazine Capsules, 35 mg. Do.
ANDA 86-524 Phenazine Capsules, 35 mg. Do.
ANDA 86-525 Phenazine Capsules, 35 mg. Do.
ANDA 86-787 Sustac (nitroglcerin) Extended-release Oral Forest Laboratories, Inc., 909 Third Ave.,
Tablets, 10 mg. New York, NY 10022-4731.
ANDA 87-255 Quinidine Sulfate Tablets, 200 mg. Solvay Pharmaceuticals, Inc., 901 Sawyer
Rd., Marietta, GA 30062.
ANDA 87-229 Nitrobon (nitroglycerin extended-release Inwood Laboratories, Inc., 909 Third Ave.,
capsules) Capsules. New York, NY 10022-4731.
ANDA 87-305 Phendimetrazine Tartrate Tablets, 35 mg. M. M. Mast & Co.
ANDA 87-544 Nitrobon (nitroglycerin extended-release Inwood Laboratories, Inc.
capsules) Capsules.
ANDA 87-917 Theophylline Syrup, 80 mg/15 mL. Ferndale Laboratories, Inc., 780 West Eight
Mile Rd., Ferndale, MI 48220.
ANDA 89-577 Hydrocortisone Sodium Succinate for Abbott Laboratories.
Injection USP, 100 mg/mL.
ANDA 89-578 A-Hydrocort (Hydrocortisone Sodium Do.
Succinate for Injection USP), 250 mg/vial.
ANDA 89-579 A-Hydrocort (Hydrocortisone Sodium Do.
Succinate for Injection USP), 500 mg/vial.
ANDA 89-580 A-Hydrocort (Hydrocortisone Sodium Do.
Succinate for Injection USP), 1 gram/vial.
----------------------------------------------------------------------------------------------------------------
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
September 22, 1999.
Dated: September 8, 1999.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-24595 Filed 9-21-99; 8:45 am]
BILLING CODE 4160-01-F
