APPLICATION
ANDA063315
TYPE
ANDA
ORIGINAL APPROVAL
1994-04-11
LATEST ACTION
2024-03-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE EQ 250MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-03-21Labeling · Supplement 23 · standardAP
2016-05-11Labeling · Supplement 15 · standardAP
2016-05-11Labeling · Supplement 16 · standardAP
2012-11-20Labeling · Supplement 12 · standardAP
2001-04-03Manufacturing (CMC) · Supplement 2AP
1997-08-08Manufacturing (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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