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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 205604

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NDA 205604 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 205604

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

Pharmacology for NDA: 205604

Medical Subject Heading (MeSH) Categories for 205604

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 205604

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	205604	ANDA	Fresenius Kabi USA, LLC	63323-815	63323-815-02	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)
AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	205604	ANDA	Fresenius Kabi USA, LLC	63323-815	63323-815-04	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/ML
Approval Date:	Dec 9, 2015	TE:	AP	RLD:	No

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