Nda Approvals

APPROVALS

As provided in § 130.33 of the FDA regulations (21 CFR 130.33), notice ha~ b~en.given .of the fol~owing ~ew drugs for 'Yhich appli,cations. or supplemental applications. for subsequent labeling changes, . have been approved. ThIS list IS pubhshed for mformation of pharmacISts but It IS not mtended to advise on the use of the products. Drugs listed may include some now approved for distribution by applications but previously marketed by other firms.

trade name Ca rd io-G reen

applicant Hynson, Westcott, and Dunning

Upjohn

Oxylone Sulla

A. H. Robins

Potassium Chloride USP Enteric Coated Tackle (Triclocarban) Medicated Soap

Richlyn Laboratories

Colgate- Pa I molive

active ingredients

how dispensed

Indocyanine green

~

principal indication Diagnostic aid for cardiac and hepatic functions

dat~

approved 2/2/59

Fluorometholone 0.025%

~

Corticosteroid

3/17/67

Sulfa meter 500 mg

~

Antibacterial sulfonamide

3/20/67

Potassium chloride, 5, 7-1/2, 10 and 15 grains

~

Prevention and treatment of potassium deficiency.

3/22/67

OTC

Antibacterial deodorant soap

3/22/67.

Triclocarban

Novaldin

Winthrop Products

Dipyrone 324 mg

~

Antipyretic

3/27/67

Ponstan

Parke, Davis

Mefenamic acid 250 mg Kapseal

~

Analgetic agent

3/28/67

Robinul Injectable

A. H. Robins

Glycopyrrolate 0.2 mg per cc

~

Anticholinergic agent for use in the treatment of gastrointestinal disorders

3/29/67

Nitrofurantoin, USP 100 mg (1-1/2 gr)

~

Antibacterial (urinary)

3/30/67

Nitrofurantoin Tablets Nixon Iron Plus for Baby Pigs Predef 2X Liquid

Arlin Chemicals

Nixon and Company Upjohn

Thibenzole

Merck & Company

Pigdex 100

American Cyanamid

Metofane

Pitman-Moore

Trolene FM

Dow Chemical

Ironyet 100

Bio-neering

Equi-Verm 800-1000

Texas Phenothiazine

Equi-Verm 500-700

Equi-Verm 300-400

360

Texas Phenothiazine

Texas Phenothiazine

Ferrous fumerate 9-Fluoroprednisolone acetate, 2 mg per cc

OTC Veterinary ~

2/3/67

Veterinary

For the treatment of bovine ketosis.

3/13/67

Thiabendazole

OTC Veterinary

For gastrointestinal infections

3/14/67

Colloidal ferric oxide

OTC Veterinary

Injectable iron for baby pig anemia

3/16/67

Induction and maintenance of general anesthesia for surgery in anImals

3/17/67

BHT (butylated hydroxy toluene) 0.01%

~

Veterinary

Ronnel, O,O-dimethyl 0

OTC Veterinary

SystemiC insecticide

3/21/67

Colloidal ferric oxide

OTC Veterinary

Injectable iron for baby pig anemia

3/21/67

Trichlorfon,O.ODimethyl 2,2,2-trichloro-1hydroxyethyl phosphonate 16.803%, Phenothiazine 29.396%

OTC Veterinary

An anthelmintic for horses

3/29/67

Trichlorfon,O.ODimethYI2,2,2-trichloro-1hydroxyethyl phosphonate 11.205% Phenothiazine 23.517%

OTC Veterinary

Trichlorfon, 0.0.DimethyI2,2,2-trichloro-1hydroxyethyl phosphonate 7.477%, Phenothiazine 17.638%

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

OTC Veterinary

An anthelmintic for horses

3/29/67

An anthelmintic for horses

3/29/67