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FDA ANDA · ANDA064146
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA064146
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-02
LATEST ACTION
1999-02-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
AMIKACIN SULFATE EQ 500MG BASE/100ML · INJECTABLE · INJECTION
Approval history
1999-02-22Manufacturing (CMC) · Supplement 1AP
1998-12-01Manufacturing (CMC) · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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