Last Updated: November 8, 2026

Details for New Drug Application (NDA): 063118

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NDA 063118 describes TOBRAMYCIN SULFATE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hainan Poly, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for 063118

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 40MG BASE/ML
Approval Date:	Jul 29, 1991	TE:		RLD:	No

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