Helen A. Ballack Co. et al.; Withdrawal of Approval of 61 New Drug Applications, 8 Abbreviated Antibiotic Applications, and 36 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0399]

Helen A. Ballack Co. et al.; Withdrawal of Approval of 61 New

Drug Applications, 8 Abbreviated Antibiotic Applications, and 36

Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval

of 61 new drug applications (NDA's), 8 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that the approval of the applications be withdrawn.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: September 25, 1997.

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,

[[Page 50388]]

by their request, waived their opportunity for a hearing.

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

Application No. Drug Applicant

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

NDA 4-526 Bal-Con Capsules Helen A. Ballack Co., 1356 Book Bldg.,

Detroit, MI 48226.

NDA 6-203 Nupercaine Heavy Solution (dibucaine Novartis Pharmaceuticals Corp., 59 Rt. 10,

hydrochloride) East Hanover, NJ 07936-1080.

NDA 6-514 Benylin (diphenhydramine hydrochloride) Warner-Lambert Co., 170 Tabor Rd., Morris

Cough Syrup 12.5 milligrams (mg)/ Plains, NJ 07950.

milliliter (mL)

NDA 6-550 ORTHOXICOL Cough Syrup The Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001-0199.

NDA 6-658 Floropryl (isoflurophate ophthalmic Merck & Co., Inc., P.O. Box 4, BLA-20, West

solution) Ophthalmic Solution Point, PA 19486.

NDA 6-921 CHLOR-TRIMETON (chlorpheniramine maleate) Schering-Plough Corp., 2000 Galloping Hill

Tablets and Syrup Rd., Kenilworth, NJ 07033.

NDA 7-635 NPH Insulin Merck Sharp & Dohme, Division of Merck &

Co., Inc.

NDA 7-757 Gantrisin (sulfoxazole diolamine ophthalmic Hoffman-LaRoche, Inc., 340 Kingsland St.,

solution) Ophthalmic Solution Nutley, NJ 07110-1199.

NDA 9-018 Hydrocortone Acetate Ophthalmic Solution Merck & Co., Inc.

and Ophthalmic Ointment

NDA 10-656 Floropryl (isoflurophate ophthalmic Do.

ointment) Ophthalmic Ointment

NDA 11-185 Reserpine Tablets USP, 0.1 mg and 0.25 mg Zenith Goldline Pharmaceuticals, Inc., 140

Legrand Ave., Northvale, NJ 07647.

NDA 11-300 Paraflex (chlorzoxazone tablet) Caplets, R. W. Johnson Pharmaceutical Research

250 mg Institute, 920 Rt. 202 South, P.O. Box

300, Raritan, NJ 08860-0602.

NDA 11-521 Rauwolfia Serpentine Tablets USP, 50 mg and Zenith Goldline Pharmaceuticals, Inc.

100 mg

NDA 11-919 Otrivin (xylometazoline hydrochloride) Novartis Pharmaceuticals, Corp., 59 Rt. 10,

East Hanover, NJ 07936-1080.

NDA 17-313 Iodohippurate Sodium I-131 Injection CIS-US, Inc., 10 De Angelo Dr., Bedford, MA

01730.

NDA 17-672 Lithonate Syrup (Lithium Citrate Syrup, Solvay Pharmaceuticals, Inc., 901 Sawyer

USP) Rd., Marietta, GA 30062.

NDA 17-792 AN-MAA, Technetium TC 99m Albumin CIS-US, Inc.

Aggregated Kit

NDA 17-996 Semilente Insulin (prompt insulin zinc Novo Nordisk Pharmaceuticals, Inc., suite

suspension, USP (Beef)) 200, 100 Overlook Center, Princeton, NJ

08540-7810.

NDA 17-997 Ultralente Insulin (extended insulin zinc Novo Nordisk.

suspension, USP (Beef))

NDA 18-125 Halog (halcinonide ointment) Ointment, Bristol-Myers Squibb Pharmaceutical

0.025% Research Institute, P.O. Box 4000,

Princeton, NJ 08543-4000.

NDA 18-055 3.3% Dextrose and 0.3% Sodium Chloride Abbott Laboratories, D-389 Bldg. AP30, 200

Injection in Flexible Containers Abbott Park Rd., Abbott Park, IL 60064-

3537.

NDA 18-384 Lentard (Purified pork and beef insulin Novo Nordisk.

zinc suspension)

NDA 18-462 Ringer's Irrigation in Flexible Containers Abbott Laboratories.

NDA 18-525 Purified beef insulin zinc suspension Novo Nordisk.

NDA 18-526 Isophane purified beef insulin suspension Do.

NDA 18-528 Purified pork insulin injection Do.

NDA 18-804 Aminosyn 3.5% and 3.5%M in Flexible Abbott Laboratories.

Containers

NDA 18-875 Aminosyn 3.5% and 3.5%M in CR3 Flexible Do.

Containers

NDA 18-923 38.5% Dextrose Injection in Flexible Do.

Containers

NDA 19-065 Novolin N NPH Human Insulin Isophane Novo Nordisk.

Suspension (semi-synthetic)

NDA 19-118 Aminosyn 3.5% and 25% Dextrose Injection Abbott Laboratories.

NDA 19-119 Aminosyn 4.25% and 25% Dextrose Injection Do.

NDA 19-120 Aminosyn 3.5% and 5% Dextrose Injection Do.

NDA 19-218 0.9% Sodium Chloride Injection in Plastic Do.

Vials

NDA 19-339 Heparin Sodium in 5% Dextrose Injection in Do.

CR3 Flexible Container

NDA 19-400 Aminosyn-HBC 7% in CR3 Flexible Containers Do.

NDA 19-449 Insulatard NPH Human (human insulin (semi- Novo Nordisk.

synthetic) isophane suspension)

NDA 19-482 5% Dextrose and 0.225% Sodium Chloride Abbott Laboratories.

Injection in 250 mL ADD-Vantage Flexible

Containers

NDA 19-483 5% Dextrose and 0.9% Sodium Chloride Do.

Injection in 250 mL ADD-Vantage Flexible

Containers

NDA 19-484 5% Dextrose and 0.45% Sodium Chloride Do.

Injection in 250 mL ADD-Vantage Flexible

Containers

NDA 19-485 Lactated Ringer's Injection in 250 mL ADD- Do.

Vantage Flexible Containers

NDA 19-486 5% Dextrose and 0.3% Sodium Chloride Do.

Injection in 250 mL ADD-Vantage Flexible

Containers

NDA 19-491 Aminosyn II 3.5% in CR3 Flexible Containers Do.

NDA 19-493 Aminosyn II 3.5M in CR3 Flexible Containers Do.

[[Page 50389]]

NDA 19-504 Aminosyn II 4.25% w/25% Dextrose in Dual- Do.

Chamber Flexible Container

NDA 19-505 Aminosyn II 3.5% w/25% Dextrose in CR3 Dual- Do.

Chamber Flexible Container

NDA 19-506 Aminosyn II 3.5% w/5% Dextrose in CR3 Dual- Do.

Chamber Flexible Container

NDA 19-712 Aminosyn II w/Electrolytes in Dextrose Do.

Injection in 2000 mL CR3 Flexible

Container

NDA 19-713 Aminosyn II in Dextrose Injection in CR3 Do.

Flexible Containers

NDA 19-714 Aminosyn II w/Electrolytes in Dextrose Do.

Injection w/Calcium in 2000 mL CR3

Flexible Container

NDA 19-837 Bretylium Tosylate in 5% Dextrose Injection Baxter Healthcare Corp., Rt. 120 and Wilson

in Plastic Container, PL 146 Rd., Round Lake, IL 60073-0490.

NDA 20-043 OMNIFLOX (temafloxacin hydrochloride) Abbott Laboratories.

Filmtab Tablets

NDA 50-188 VINACTANE (sterile viomycin sulfate) Novartis Pharms, 556 Morris Ave., Summit,

NJ 07901.

NDA 50-019 Penbritin Drops Wyeth-Ayerst Laboratories, P.O. Box 8299,

Philadelphia, PA 19101-8299.

NDA 50-028 DYNAPEN (Dicloxacillin sodium menohydrate) Bristol-Myers, U.S. Pharmaceutical Group,

Capsules Evansville, IN 47721-0001.

NDA 50-029 Hetacillin Potassium, Sterile Bristol-Myers Squibb Co., P.O. Box 4755,

Syracuse, NY 13221-4755.

NDA 50-134 SYNCILLIN (phenethicillin potassium) O.S. Bristol-Myers, U.S. Pharmaceutical Group.

NDA 50-328 Methicillin Sodium Bristol-Myers Squibb Co.

NDA 50-378 Neohydeltrasol (neomycin sulfate/ Merck & Co., Inc.

prednisolone sodium sulfate ophthalmic

ointment) Ophthalmic Ointment

NDA 50-562 Azlin (azlocillin sodium) Miles, Pharmaceutical Division, 400 Morgan

Lane, West Haven, CT 06516-4175.

NDA 50-618 AMIKIN (amikacin sulfate) in 0.9% NaCL (PVC Apothecon, P.O. Box 4500, Princeton, NJ

flexible containers) 08543-4500.

AADA 60-291 Tetracycline Oral Suspension USP, 125 mg/5 Purepac Pharmaceutical Co., 200 Elmora

mL Ave., Elizabeth, NJ 07207.

AADA 62-218 Ampicillin Trihydrate, bulk drug ACS Dobfar SpA, U.S. Agent: Interchem

Corp., 120 Rt. 17 North, P.O. Box 1579,

Paramus, NJ 07653-1579.

AADA 62-319 Tetracycline Hydrochloride (bulk, Tianjin Pharmaceuticals Corp., U.S. Agent:

nonsterile) Darsheng Trade & Tech. Dev. Co., Ltd.,

P.O. Box 1220, 655 Amboy Ave., A-wing, 1st

Fl., Woodbridge, NJ 07095.

AADA 62-387 Nystatin Cream USP, 100,000 Units/g Alpharma, U.S. Pharmaceuticals Div., Johns

Hopkins Bayview Center, 333 Cassell Dr.,

suite 3500, Baltimore, MD 21224.

AADA 62-571 Nystatin Oral Suspension USP, 100,000 Units/ Do.

mL

AADA 62-731 Nystatin Ointment USP, 100,000 Units/g Do.

AADA 62-809 Cephalexin Capsules USP, 250 mg and 500 mg Purepac Pharmaceutical.

AADA 62-942 Cyclacilin, bulk drug ACS Dobfar SpA.

ANDA 70-580 Allopurinol Tablets, USP, 300 mg Purepac Pharmaceutical.

ANDA 71-085 Betamethasone Dipropionate Lotion USP, Alpharma.

0.05%

ANDA 71-798 Triprolidine and Pseudo-ephedrine KV Pharmaceutical Co., 2503 South Hanley

Hydrochlorides Extended-Release Capsules, Rd., St. Louis, MO 63144-2555.

5 mg/120 mg

ANDA 71-924 Clorazepate Dipotassium Capsules, 3.75 mg Purepac Pharmaceutical.

ANDA 71-925 Clorazepate Dipotassium Capsules, 7.5 mg Do.

ANDA 71-926 Clorazepate Dipotassium Capsules, 15 mg Do.

ANDA 80-087 Sulfisoxazole Tablets USP, 500 mg Do.

ANDA 80-395 Hydrocortisone Tablets, 20 mg Do.

ANDA 83-271 Niacin Tablets, 500 mg Do.

ANDA 84-020 Triamcinolone Tablets USP, 4 mg Do.

ANDA 84-247 Hydrocortisone Tablets, 10 mg Do.

ANDA 84-804 Meprobamate Tablets USP, 200 mg and 400 mg Do.

ANDA 84-939 Chlordiazepoxide Hydrochloride Capsules Do.

USP, 10 mg

ANDA 85-144 Chlordiazepoxide Hydrochloride Capsules Do.

USP, 25 mg

ANDA 85-155 Chlordiazepoxide Hydrochloride Capsules Do.

USP, 5 mg

ANDA 85-753 Liothyronine Sodium Tablets, 50 micrograms Bolar Pharmaceutical Co., Inc., 130 Lincoln

St., Copiague, NY 11726.

ANDA 85-904 Isoproterenol Hydrochloride Inhalation Alpharma.

Aerosol USP, 0.25%

ANDA 86-110 Sustachron (Nitroglycerin Extended-release) Forest Laboratories, Inc., 909 Third Ave.,

Oral Tablets, 6.5 mg New York, NY 10022-4731.

ANDA 86-112 Sustachron (Nitroglycerin Extended-release) Do.

Oral Tablets, 2.6 mg

ANDA 86-649 Sustachron (Nitroglycerin) Tablets, 10 mg Do.

ANDA 87-110 Nitroglycerin Extended-release Capsules KV Pharmaceutical Co.

ANDA 87-683 Pentaerythritol Tetra-nitrate Extended- Inwood Laboratories, Inc., 909 Third Ave.,

release Capsules, 80 mg New York, NY 10022-4731.

ANDA 87-995 THEO-DUR (Theophylline Sustained-release Schering Corp., 2000 Galloping Hill Rd.,

Capsules) Sprinkle, 200 mg Kenilworth, NJ 07033.

[[Page 50390]]

ANDA 88-015 THEO-DUR (Theophylline Sustained-release Do.

Capsules) Sprinkle, 75 mg

ANDA 88-016 THEO-DUR (Theophylline Sustained-release Do.

Capsules) Sprinkle, 125 mg

ANDA 88-022 THEO-DUR (Theophylline Sustained-release Do.

Capsules) Sprinkle, 50 mg

ANDA 88-066 Hydrocone Bitartrate and Homatropine Halsey Drug Co., 1827 Pacific St.,

Methylbromide Syrup, 5 mg/1.5 mg per5 mL Brooklyn, NY 11233.

ANDA 88-112 Tripodrine (Triprolidine and Danbury Pharmacal, Inc., 131 West St.,

Pseudoephedrine Hydrochlorides Tablets Danbury, CT 06810.

USP) 2.5 mg/60 mg

ANDA 88-140 Chlorthalidone Tablets USP, 50 mg Purepac Pharmaceutical.

ANDA 88-178 Hydralazine Hydrochloride Tablets, 50 mg Do.

ANDA 88-360 Fluocinolone Acetonide Cream USP, 0.025% Alpharma.

ANDA 88-361 Fluocinolone Acetonide Cream USP, 0.01% Do.

ANDA 88-950 Tolbutamide Tablets, 500 mg Purepac Pharmaceutical.

ANDA 88-997 Dexamethasone Elixir USP, 0.5 mg/5 mL Alpharma.

ANDA 89-754 Hydrocortisone Cream USP, 2.5% Do.

ANDA 89-840 Procainamide Hydrochloride Extended-release Inwood Laboratories.

Tablets, 500 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

September 25, 1997.

Dated: September 11, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 97-25369 Filed 9-24-97; 8:45 am]

BILLING CODE 4160-01-F