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Details for New Drug Application (NDA): 063313

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NDA 063313 describes AMIKACIN SULFATE, which is a drug marketed by Fresenius Kabi Usa, West-ward Pharms Int, Sagent Pharms, Emcure Pharms Ltd, Teva Pharms Usa, Hospira, Abbott, Igi Labs Inc, and Eurohlth Intl Sarl, and is included in twenty 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. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

Summary for NDA: 063313

West-ward Pharms Int
amikacin sulfate
Therapeutic Class:Antibacterials

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Apr 11, 1994TE:APRLD:Yes

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