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Last Updated: March 19, 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, and Sagent Pharms Inc, and is included in twenty NDAs. It is available from four 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 064045
Tradename:AMIKACIN SULFATE
Applicant:Meitheal
Ingredient:amikacin sulfate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 064045

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Sep 28, 1993TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Sep 28, 1993TE:APRLD:No

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