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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 063313

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NDA 063313 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 are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

Summary for 063313

Tradename:	AMIKACIN SULFATE
Applicant:	Hikma
Ingredient:	amikacin sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 063313

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Apr 11, 1994	TE:		RLD:	No

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