APPLICATION
ANDA063283
TYPE
ANDA
ORIGINAL APPROVAL
1994-10-31
LATEST ACTION
2001-04-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMIKACIN SULFATEDiscontinued
AMIKACIN SULFATE EQ 62.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2001-04-09Manufacturing (CMC) · Supplement 5AP
1998-12-14Manufacturing (CMC) · Supplement 4AP
1998-12-14Manufacturing (CMC) · Supplement 3AP
1997-06-18Manufacturing (CMC) · Supplement 2AP
1994-10-31OriginalAP
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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