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Last Updated: January 9, 2026

Details for New Drug Application (NDA): 063113

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NDA 063113 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 ten 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. Ten suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for 063113

Tradename:	TOBRAMYCIN SULFATE
Applicant:	Hikma
Ingredient:	tobramycin sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Apr 26, 1991	TE:		RLD:	No

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