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FDA ANDA · ANDA063350

AMIKACIN SULFATE

Sponsor: HOSPIRA

APPLICATION
ANDA063350
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
2001-09-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMIKACIN SULFATEDiscontinued
AMIKACIN SULFATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
AMIKACIN SULFATEDiscontinued
AMIKACIN SULFATE EQ 250MG BASE/ML · INJECTABLE · INJECTION

Approval history

2001-09-17Manufacturing (CMC) · Supplement 3AP
1999-07-01Manufacturing (CMC) · Supplement 2AP
1997-07-10Manufacturing (CMC) · Supplement 1AP
1993-07-30OriginalAP
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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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