[Federal Register Volume 62, Number 234 (Friday, December 5, 1997)]
[Notices]
[Pages 64385-64387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31879]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0480]
Zenith Goldline Pharmaceuticals; Withdrawal of Approval of 11
Abbreviated Antibiotic Applications and 105 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 11 abbreviated antibiotic applications (AADA's) and 105 abbreviated
new drug applications (ANDA's). Zenith Goldline Pharmaceuticals
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withdrawn.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: January 5, 1998.
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: Zenith Goldline Pharmaceuticals, 140 Legrand
Ave., Northvale, NJ 07647, has informed FDA that the drug products
listed in the following table are no longer marketed and has requested
that FDA withdraw approval of the applications. Zenith Goldline
Pharmaceuticals has also, by its request, waived its opportunity for a
hearing.
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Application No. Drug
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AADA 60-072.......................... Penicillin G Potassium Powder,
100,000 units/5 milliliters
(mL), 200,000 units/5 mL,
250,000 units/5 mL, 400,000
units/5 mL, 500,000 units/5 mL
AADA 60-073.......................... Penicillin G Potassium Tablets
USP, 100,000 units/Tab, 200,000
units/Tab, 250,000 units/Tab,
400,000 units/Tab, 500,000 units/
Tab
AADA 60-104.......................... Chlortetracycline Hydrochloride
(HCl) Capsules USP, 250
milligrams (mg)
AADA 60-518.......................... Penicillin V Potassium Tablets
USP, 125 mg, 250 mg, 500 mg
AADA 60-519.......................... Penicillin V Potassium Powder,
125 mg/5 mL, 250 mg/5 mL
AADA 60-692.......................... Ampicillin Capsules USP
(Trihydrate), 250 mg, 500 mg
AADA 60-765.......................... Ampicillin Capsules USP
(Trihydrate), 250 mg, 500 mg
AADA 61-183.......................... Ampicillin for Oral Suspension
USP, 125 mg/5 mL, 250 mg/5 mL
AADA 61-468.......................... Tetracycline Syrup, 125 mg/5 mL
AADA 62-237.......................... Erythromycin Estolate Capsules
USP, 250 mg
AADA 62-762.......................... Cephradine Capsules USP, 250 mg,
500 mg
ANDA 70-360.......................... Diazepam Tablets USP, 2 mg
ANDA 70-361.......................... Diazepam Tablets USP, 5 mg
ANDA 70-362.......................... Diazepam Tablets USP, 10 mg
ANDA 70-935.......................... Perphenazine and Amitriptyline
HCl Tablets USP, 2 mg/10 mg
ANDA 70-936.......................... Perphenazine and Amitriptyline
HCl Tablets USP, 2 mg/25 mg
ANDA 70-937.......................... Perphenazine and Amitriptyline
HCl Tablets USP, 4 mg/10 mg
ANDA 70-938.......................... Perphenazine and Amitriptyline
HCl Tablets USP, 4 mg/25 mg
ANDA 70-939.......................... Perphenazine and Amitriptyline
HCl Tablets USP, 4 mg/50 mg
ANDA 71-154.......................... Ibuprofen Tablets USP, 200 mg
(Round)
ANDA 71-458.......................... Methyldopa and
Hydrochlorothiazide Tablets USP,
250 mg/15 mg
ANDA 71-459.......................... Methyldopa and
Hydrochlorothiazide Tablets USP,
250 mg/25 mg
ANDA 71-460.......................... Methyldopa and
Hydrochlorothiazide Tablets USP,
500 mg/30 mg
ANDA 71-461.......................... Methyldopa and
Hydrochlorothiazide Tablets USP,
500 mg/50 mg
ANDA 71-552.......................... Propranolol HCl and
Hydrochlorothiazide Tablets USP,
40 mg/25 mg
ANDA 71-553.......................... Propranolol HCl and
Hydrochlorothiazide Tablets USP,
80 mg/25 mg
ANDA 72-040.......................... Ibuprofen Tablets USP, 200 mg
(Caplet)
ANDA 72-063.......................... Propranolol HCl Tablets USP, 10
mg
ANDA 72-066.......................... Propranolol HCl Tablets USP, 20
mg
ANDA 72-067.......................... Propranolol HCl Tablets USP, 40
mg
ANDA 72-068.......................... Propranolol HCl Tablets USP, 60
mg
ANDA 72-069.......................... Propranolol HCl Tablets USP, 80
mg
ANDA 80-078.......................... Nitrofurantoin Tablets
(Microcrystalline) 50 mg, 100 mg
ANDA 80-143.......................... Trisulfapyrimidines Tablets USP
ANDA 80-215.......................... Propylthiouracil Tablets USP, 50
mg
ANDA 80-270.......................... Isoniazid Tablets USP, 100 mg
ANDA 80-283.......................... Prednisone Tablets USP, 5 mg
ANDA 80-378.......................... Prednisolone Tablets USP, 5 mg
ANDA 80-630.......................... Cortisone Acetate Tablets USP, 25
mg
ANDA 80-735.......................... Dimenhydrinate Tablets USP, 50 mg
ANDA 80-762.......................... Diphenhydramine HCl Capsules USP,
25 mg, 50 mg
ANDA 80-779.......................... Chlorphenirarnine Maleate Tablets
USP, 4 mg
ANDA 83-035.......................... Vitamin A Capsules USP, 50,000
units
ANDA 83-077.......................... Propoxyphene Compound Capsules
[[Page 64386]]
ANDA 83-180.......................... Niacin Tablets USP, 500 mg
ANDA 83-190.......................... Vitamin A Palmitate Capsules,
50,000 units
ANDA 83-416.......................... Dexamethasone Tablets USP, 0.75
mg
ANDA 83-461.......................... Pentobarbital Sodium Capsules
USP, 50 mg, 100 mg
ANDA 83-484.......................... Butabarbital Sodium Tablets USP,
15 mg
ANDA 83-536.......................... Cortisone Acetate Tablets USP, 25
mg
ANDA 83-549.......................... Chlorpromazine HCl Tablets USP,
10 mg, 25 mg, 50 mg
ANDA 83-568.......................... Reserpine and Hydrochlorothiazide
Tablets USP, 0.1 mg/50 mg
ANDA 83-570.......................... Chlordiazepoxide HCl Capsules
USP, 25 mg
ANDA 83-571.......................... Reserpine and Hydrochlorothiazide
Tablets USP, 0.125 mg/25 mg
ANDA 83-572.......................... Reserpine and Hydrochlorothiazide
Tablets USP, 0.1 mg/25 mg
ANDA 83-573.......................... Reserpine and Hydrochlorothiazide
Tablets USP, 0.125 mg/50 mg
ANDA 83-574.......................... Chlorpromazine HCl Tablets USP,
100 mg
ANDA 83-575.......................... Chlorpromazine HCl Tablets USP,
200 mg
ANDA 83-597.......................... Propoxyphene HCl Capsules USP, 32
mg
ANDA 83-603.......................... Promethazine HCl Tablets USP, 25
mg
ANDA 83-604.......................... Promethazine HCl Tablets USP,
12.5 mg
ANDA 83-610.......................... Isoniazid Tablets USP, 300 mg
ANDA 83-613.......................... Promethazine HCl Tablets USP, 50
mg
ANDA 83-741.......................... Chlordiazepoxide HCl Capsules
USP, 5 mg
ANDA 83-742.......................... Chlordiazepoxide HCl Capsules
USP, 10 mg
ANDA 83-750.......................... Triamcinolone Tablets USP, 4 mg
ANDA 83-784.......................... Meclizine HCl Tablets USP, 12.5
mg
ANDA 83-876.......................... Hydralazine HCl and
Hydrochlorothiazide Tablets, 25
mg/15 mg
ANDA 83-877.......................... Reserpine, Hydralazine HCl, and
Hydrochlorothiazide Tablets USP,
0.1 mg/25 mg/15 mg
ANDA 84-040.......................... Butabarbital Sodium Tablets USP,
30 mg
ANDA 84-133.......................... Prednisone Tablets USP, 10 mg
ANDA 84-134.......................... Prednisone Tablets USP, 20 mg
ANDA 84-181.......................... Meprobamate Tablets USP, 600 mg
ANDA 84-291.......................... Reserpine, Hydralazine HCl and
Hydrochlorothiazide Tablets USP,
0.1 mg/25 mg/15 mg
ANDA 84-351.......................... Brompheniramine Maleate Tablets
USP, 4 mg
ANDA 84-437.......................... Hydralazine HCl Tablets USP, 25
mg
ANDA 84-443.......................... Hydralazine HCl Tablets USP, 10
mg
ANDA 84-469.......................... Hydralazine HCl Tablets USP, 50
mg
ANDA 84-473.......................... Isosorbide Dinitrate Sublingual
Tablets USP, 2.5 mg
ANDA 84-474.......................... Isosorbide Dinitrate Sublingual
Tablets USP, 5 mg
ANDA 84-549.......................... Quinidine Sulfate Tablets USP,
200 mg
ANDA 84-581.......................... Hydralazine HCl Tablets USP, 100
mg
ANDA 84-648.......................... Methocarbamol Tablets USP, 500 mg
ANDA 84-649.......................... Methocarbamol Tablets USP, 750 mg
ANDA 84-658.......................... Hydrochlorothiazide Tablets USP,
50 mg
ANDA 84-689.......................... Bethanechol Chloride Tablets USP,
25 mg
ANDA 84-976.......................... Meclizine HCl Tablets USP, 25 mg
ANDA 85-273.......................... Triprolidine and Pseudoephedrine
Hydrochlorides Tablets USP, 2.5
mg/60 mg
ANDA 85-441.......................... Butalbital Compound Tablets USP,
50 mg/325 mg
ANDA 85-553.......................... Phenterimine HCl Tablets, 8 mg
ANDA 85-611.......................... Phendimetrazine Tartrate Tablets
USP, 35 mg
ANDA 85-612.......................... Phendimetrazine Tartrate Tablets
USP, 35 mg
ANDA 85-682.......................... Phendimetrazine Tartrate Tablets
USP, 35 mg
ANDA 85-869.......................... Secobarbital Sodium Capsules USP,
100 mg
ANDA 86-035.......................... Isosorbide Dinitrate Tablets USP,
10 mg
ANDA 86-329.......................... Phentermine HCl Capsules USP, 30
mg
ANDA 87-004.......................... Spironolactone and
Hydrochlorothiazide Tablets USP,
25 mg/25 mg
ANDA 87-008.......................... Dipyridamole Tablets USP, 25 mg
ANDA 87-108.......................... Spironolactone Tablets USP, 25 mg
ANDA 87-186.......................... Ergoloid Mesylates Tablets USP
(Sublingual), 0.5 mg
ANDA 87-216.......................... Hydroxyzine HCl Tablets USP, 10
mg
ANDA 87-316.......................... Dipyridamole Tablets USP, 50 mg
ANDA 87-320.......................... Dipyridamole Tablets USP, 75 mg
ANDA 87-353.......................... Chlorpropamide Tablets USP, 250
mg
ANDA 87-410.......................... Hydroxyzine HCl Tablets USP, 25
mg
ANDA 87-411.......................... Hydroxyzine HCl Tablets USP, 50
mg
ANDA 87-555.......................... Chlorthalidone Tablets USP, 25 mg
ANDA 87-769.......................... Sulfinpyrazone Tablets USP, 100
mg
ANDA 87-786.......................... Methyclothiazine Tablets USP, 5
mg
ANDA 87-947.......................... Chlorthalidone Tablets USP, 50 mg
ANDA 88-218.......................... Phenylbutazone Capsules USP, 100
mg
ANDA 88-356.......................... Hydralazine HCl and
Hydrochlorothiazide Capsules, 25
mg/25 mg
ANDA 88-357.......................... Hydralazine HCl and
Hydrochlorothiazide Capsules, 50
mg/50 mg
ANDA 88-358.......................... Hydralazine HCl and
Hydrochlorothiazide Capsules,
100 mg/50 mg
ANDA 88-840.......................... Chlorpropamide Tablets USP, 100
mg
[[Page 64387]]
ANDA 88-932.......................... Reserpine and Hydroflumethiazide
Tablets, 0.125 mg/50 mg
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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 in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
January 5, 1998.
Dated: November 17, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-31879 Filed 12-4-97; 8:45 am]
BILLING CODE 4160-01-F