Last Updated: September 28, 2026

Details for New Drug Application (NDA): 063169

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NDA 063169 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, and Sagent Pharms Inc, and is included in twenty-one NDAs. It is available from six suppliers. Additional details are available on the AMIKACIN SULFATE profile page.

The generic ingredient in AMIKACIN SULFATE is amikacin sulfate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

Summary for 063169

Tradename:	AMIKACIN SULFATE
Applicant:	Igi Labs Inc
Ingredient:	amikacin sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 063169

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/ML
Approval Date:	Dec 14, 1995	TE:		RLD:	No

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