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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 065013

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NDA 065013 describes TOBRAMYCIN SULFATE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-two NDAs. It is available from eleven suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.

The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for 065013

Tradename:	TOBRAMYCIN SULFATE
Applicant:	Xgen Pharms
Ingredient:	tobramycin sulfate
Patents:	0

Pharmacology for NDA: 065013

Suppliers and Packaging for NDA: 065013

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065013	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0412	39822-0412-1	1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL
TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065013	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0412	39822-0412-6	6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1.2GM BASE/VIAL
Approval Date:	Aug 17, 2001	TE:	AP	RLD:	No

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