Details for New Drug Application (NDA): 064056

NDA 064056 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Taro, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, Fera Pharms Llc, Sciegen Pharms Inc, Encube, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Paco, Sandoz, B Braun, and Baxter Hlthcare, and is included in forty NDAs. It is available from twenty-three suppliers. Additional details are available on the GENTAMICIN SULFATE profile page.

The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

Summary for 064056

Tradename:	GENTAMICIN SULFATE
Applicant:	Cosette
Ingredient:	gentamicin sulfate
Patents:	0

Pharmacology for NDA: 064056

Suppliers and Packaging for NDA: 064056

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GENTAMICIN SULFATE	gentamicin sulfate	CREAM;TOPICAL	064056	ANDA	Cosette Pharmaceuticals, Inc.	0713-0683	0713-0683-15	1 TUBE in 1 CARTON (0713-0683-15) / 15 g in 1 TUBE
GENTAMICIN SULFATE	gentamicin sulfate	CREAM;TOPICAL	064056	ANDA	Cosette Pharmaceuticals, Inc.	0713-0683	0713-0683-31	1 TUBE in 1 CARTON (0713-0683-31) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 0.1% BASE
Approval Date:	Apr 29, 1994	TE:	AT	RLD:	No

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