Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203323

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NDA 203323 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 203323

Tradename:	AMIKACIN SULFATE
Applicant:	Sagent Pharms Inc
Ingredient:	amikacin sulfate
Patents:	0

Pharmacology for NDA: 203323

Medical Subject Heading (MeSH) Categories for 203323

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 203323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	203323	ANDA	Sagent Pharmaceuticals	25021-173	25021-173-02	10 VIAL in 1 CARTON (25021-173-02) / 2 mL in 1 VIAL
AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	203323	ANDA	Sagent Pharmaceuticals	25021-173	25021-173-04	10 VIAL in 1 CARTON (25021-173-04) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/ML
Approval Date:	May 12, 2016	TE:	AP	RLD:	No

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