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Generated: June 26, 2017

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Details for New Drug Application (NDA): 063169

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NDA 063169 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, and Igi Labs Inc, 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: 063169

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Dec 14, 1995TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Colorcon
Baxter
McKesson
Julphar
Cantor Fitzgerald
QuintilesIMS
Argus Health
Mallinckrodt
Healthtrust
Teva

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