Details for New Drug Application (NDA): 215237

NDA 215237 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Sun Pharma Canada, 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 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-four suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

Summary for 215237

Tradename:	GENTAMICIN SULFATE
Applicant:	Eugia Pharma
Ingredient:	gentamicin sulfate
Patents:	0

Pharmacology for NDA: 215237

Suppliers and Packaging for NDA: 215237

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	215237	ANDA	Eugia US LLC	55150-402	55150-402-25	25 VIAL, MULTI-DOSE in 1 CARTON (55150-402-25) / 2 mL in 1 VIAL, MULTI-DOSE (55150-402-01)
GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	215237	ANDA	Eugia US LLC	55150-403	55150-403-25	25 VIAL, MULTI-DOSE in 1 CARTON (55150-403-25) / 20 mL in 1 VIAL, MULTI-DOSE (55150-403-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 40MG BASE/ML
Approval Date:	Jan 8, 2024	TE:	AP	RLD:	No

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