APPLICATION
ANDA063264
TYPE
ANDA
ORIGINAL APPROVAL
1994-11-30
LATEST ACTION
2004-03-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMIKACIN SULFATEDiscontinued
AMIKACIN SULFATE EQ 250MG BASE/ML · INJECTABLE · INJECTION
Approval history
2004-03-10Labeling · Supplement 12AP
2003-05-13Labeling · Supplement 11AP
2002-10-25Manufacturing (CMC) · Supplement 10AP
2002-09-27Labeling · Supplement 9AP
2001-03-22Manufacturing (CMC) · Supplement 8AP
2001-03-22Manufacturing (CMC) · Supplement 7AP
2000-01-07Labeling · Supplement 6AP
2000-01-07Manufacturing (CMC) · Supplement 5AP
1997-06-18Manufacturing (CMC) · Supplement 4AP
1996-10-03Manufacturing (CMC) · Supplement 2AP
1994-11-30OriginalAP
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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