APPLICATION
ANDA063274
TYPE
ANDA
ORIGINAL APPROVAL
1992-05-18
LATEST ACTION
2023-01-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMIKACIN SULFATEDiscontinued
AMIKACIN SULFATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-31Labeling · Supplement 2 · standardAP
1993-04-20Manufacturing (CMC) · Supplement 1AP
1992-05-18OriginalAP
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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