APPLICATION
ANDA063313
TYPE
ANDA
ORIGINAL APPROVAL
1994-04-11
LATEST ACTION
2023-01-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-24Labeling · Supplement 14 · standardAP
2012-11-20Labeling · Supplement 12 · standardAP
2001-04-03Manufacturing (CMC) · Supplement 3AP
1997-08-04Manufacturing (CMC) · Supplement 2AP
1995-02-23Manufacturing (CMC) · Supplement 1AP
1994-04-11OriginalAP
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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