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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 064045

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NDA 064045 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 five 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. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

Summary for 064045

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

Medical Subject Heading (MeSH) Categories for 064045

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Sep 28, 1993	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/ML
Approval Date:	Sep 28, 1993	TE:	AP	RLD:	No

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