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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218146

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NDA 218146 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 218146

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

Pharmacology for NDA: 218146

Medical Subject Heading (MeSH) Categories for 218146

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 218146

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	218146	ANDA	Qilu Pharmaceutical Co., Ltd.	67184-0569	67184-0569-2	10 VIAL, GLASS in 1 CARTON (67184-0569-2) / 2 mL in 1 VIAL, GLASS (67184-0569-1)
AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	218146	ANDA	Qilu Pharmaceutical Co., Ltd.	67184-0570	67184-0570-2	10 VIAL, GLASS in 1 CARTON (67184-0570-2) / 4 mL in 1 VIAL, GLASS (67184-0570-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/ML
Approval Date:	Mar 19, 2024	TE:	AP	RLD:	No

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