[Federal Register Volume 64, Number 184 (Thursday, September 23, 1999)]
[Notices]
[Pages 51546-51548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24720]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4006]


Beecham Laboratories et al.; Withdrawal of Approval of 44 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 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be withdrawn.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 23, 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.

[[Page 51547]]



 
--------------------------------------------------------------------------------------------------------------------------------------------------------
        ANDA No.                                       Drug                                                          Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
60-680                    Ampicillin for Oral Suspension, 125 milligrams (mg)/5           Beecham Laboratories, 1 Franklin Plaza, P.O. Box 7929,
                           milliliters (mL) and 250 mg/5 mL.                               Philadelphia, PA 19101-7929.
60-922                    Neomycin Sulfate-Hydrocortisone Topical Ointment.               Teva Pharmaceuticals, USA, 1510 Delp Dr., Kulpsville, PA
                                                                                           19443.
61-598                    Ampicillin Trihydrate Capsules USP, 250 mg and 500 mg.          Pharmacia & Upjohn, 7000 Portage Rd., Kalamazoo, MI 49001-
                                                                                           0199.
61-599                    Ampicillin Trihydrate for Oral Suspension USP, 125 mg/5 mL and  Do.
                           250 mg/5 mL.
61-934                    Sterile Ampicillin Sodium USP.                                  Bristol-Myers Squibb Pharmaceutical Research Institute, P.O.
                                                                                           Box 4000, Princeton, NJ 08543-4000.
61-935                    Penicillin G Sodium for Injection USP, 5,000,000 units per       Do.
                           vial.
62-425                    Bacitracin-Polymyxin B Sulfate-Neomycin Sulfate Topical          Blistex Inc., 1800 Swift Dr., Oak Brook, IL 60532-1574.
                           Ointment.
62-595                     Neomycin Sulfate-Triamcinolone Acetonide Cream.                Pharmaderm, Division of Altana Inc., 60 Baylis Rd., Melville,
                                                                                           NY 11747.
62-600                    Neomycin Sulfate-Triamcinolone Acetonide Cream.                 E. Fougers & Co., Division of Altana Inc., 60 Baylis Rd.,
                                                                                           Melville, NY 11747.
62-608                    Neomycin Sulfate-Tramcinolone Acetonide Ointment.               Do.
62-609                    Neomycin B Sulfate and Triamcinolone Acetonide Ointment.         Savage Laboratories, Inc., Division of Altana Inc., 60 Baylis
                                                                                           Rd., Melville, NY 11747.
71-497                    Anticoagulant Citrate Dextrose Solution USP.                     Miles, Inc., 800 Dwight Way, Berkeley, CA 94701-1986.
72-374                    PORTALAC (Lactulose Solution USP) 10 g/15 mL.                   Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA
                                                                                           30062.
80-414                    Lidocaine Hydrochloride Injection USP, 1% and 2%.               Miles, Inc.
80-415                    Procaine Hydrochloride Injection USP, 1% and 2%.                Do.
80-570                    Cyanocobalamin Injection USP, 1,000 micrograms (mcg)/mL.        Savage Laboratories, Inc.
80-982                    Ergocalciferol Capsules USP.                                    Pharmacia & Upjohn.
81-274                    Hydrocortisone Acetate Cream 1%.                                Able Laboratories Inc., 6 Hollywood Ct., South Plainfield, NJ
                                                                                           07080.
84-059                    Hydrocortisone Cream 1%                                         G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ
                                                                                           07080-3895.
84-438                    Meprobamate Tablets USP, 400 mg.                                Pharmavite Corp., 15451 San Fernando Mission Blvd., P.O. Box
                                                                                           9606, Mission Hills, CA 91346-9606.
84-463                    Ethchlorvynol Capsules USP, 100, 200, 500, and 750 mg.          Banner Gelatine Products Corp., 4125 Premier Dr., P.O. Box
                                                                                           2210, High Point, NC 27261-2210.
84-573                    DERMACORT (Hydrocortisone Lotion USP) 0.5%.                     Solvay Pharmaceuticals, Inc.
84-662                    Prednisone Tablets USP, 5 mg.                                   Pharmavite Corp.
84-663                    Reserpine Tablets USP, 0.25 mg.                                 Do.
84-664                    Prednisolone Tablets USP, 5 mg.                                 Do.
84-693                    Prophoxyphene Hydrochloride Capsules USP, 32 mg and 65 mg.      Do.
84-707                    Triamcinolone Tablets, 8 mg.                                    Roxane Laboratories, Inc., P.O. 16532, Columbus, OH 43216-
                                                                                           6532.
84-709                    Triamcinolone Tablets, 4 mg.                                    Do.
84-991                    DEXONE (Dexamethasone Tablets USP) 0.5 mg.                      Solvay Pharmaceuticals, Inc.
84-992                    DEXONE (Dexamethasone Tablets USP) 4 mg.                        Do.
84-993                    DEXONE (Dexamethasone Tablets USP) 0.75 mg.                     Do.
85-024                    Triproldine Hydrochloride and Pseudophedrine Hydrochloride      MD Pharmaceuticals, Inc., 3501 W. Garry Ave., Santa Ana, CA
                           Tablets, 2.5 mg/60 mg.                                          92704.
85-134                    Acetaminophen Tablets, 325 mg and Oxycodone/Acetaminophen       Bristol-Myers Squibb Co., Pharmaceutical Group, P.O. Box 4755,
                           Tablets (Oxycodone Hydrochloride 4.5 mg, Oxycodone              Syracuse, NY 13221-4755.
                           Terephthalate 0.38 mg, Acetaminophen 325 mg).
85-685                    PROVAL #3 (Acetaminophen and Codeine Phosphate) Capsules, 325   Solvay Pharmaceuticals, Inc.
                           mg/30 mg.
85-893                    UNIPRES (Reserpine, Hydralazine Hydrochloride, and              Do.
                           Hydrochlorothiazine) Tablets (peach) 0.1/25/15 mg.
85-999                    ORASONE (Prednisone Tablets USP) 50 mg.                         Do.
86-296                    Folic Acid 1 mg.                                                Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd., Charlotte,
                                                                                           NC 28206.
86-462                    DERMACORT (Hydrocortisone Lotion USP) 1%.                       Solvay Pharmaceuticals, Inc.
87-213                    Hydralazine Hydrochloride and Hydrochlorothiazide Capsules, 50  Do.
                           mg/50 mg.
87-228                    Chloroquine Phosphate Tablets.                                  MD Pharmaceuticals, Inc.
87-566                    Cyproheptadine Hydrochloride Tablets, 4 mg.                     Do.
87-608                    Hydralazine Hydrochloride and Hydrochlorothiazide Capsules 25   Solvay Pharmaceuticals, Inc.
                           mg/25 mg.
88-376                    Reserpine, Hydralazine Hydrochloride, and Hydrochlorothiazide   Do.
                           Tablets USP, 0.1 mg/25 mg/15 mg.
89-913                    Triamcinolone Acetonide Ointment USP, 0.5%.                     Alpharma, U.S. Pharmaceuticals Division, 333 Cassell Dr.,
                                                                                           suite 3500, Baltimore, MD 21224.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 51548]]

     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 23, 1999.

    Dated: September 8, 1999.
 Janet Woodcock
 Director, Center for Drug Evaluation and Research.
[FR Doc. 99-24720 Filed 9-22-99; 8:45 am]
BILLING CODE 4160-01-F