APPLICATION
ANDA064045
TYPE
ANDA
ORIGINAL APPROVAL
1993-09-28
LATEST ACTION
2023-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE EQ 250MG BASE/ML · INJECTABLE · INJECTION
AMIKACIN SULFATEDiscontinued
AMIKACIN SULFATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 40 · standardAP
2023-01-24Labeling · Supplement 34 · standardAP
2023-01-24Labeling · Supplement 29 · standardAP
2015-05-29Labeling · Supplement 25 · standardAP
2013-02-20Labeling · Supplement 24 · standardAP
2012-05-17Manufacturing (CMC) · Supplement 18AP
1996-07-03Manufacturing (CMC) · Supplement 2AP
1995-06-02Manufacturing (CMC) · Supplement 1AP
1993-09-28OriginalAP
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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