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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 205605

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NDA 205605 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 205605

Tradename:	AMIKACIN SULFATE
Applicant:	Fresenius Kabi Usa
Ingredient:	amikacin sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 205605

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Dec 9, 2015	TE:		RLD:	No

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