Details for New Drug Application (NDA): 062251

NDA 062251 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 062251

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

Pharmacology for NDA: 062251

Suppliers and Packaging for NDA: 062251

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	062251	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9128	0143-9128-25	25 VIAL in 1 CARTON (0143-9128-25) / 2 mL in 1 VIAL (0143-9128-01)
GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	062251	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9129	0143-9129-10	10 VIAL in 1 CARTON (0143-9129-10) / 20 mL in 1 VIAL (0143-9129-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 40MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

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