APPLICATION
ANDA204040
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-12
LATEST ACTION
2023-02-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE EQ 250MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 21 · standardAP
2019-12-13Labeling · Supplement 10 · standardAP
2019-12-13Labeling · Supplement 5 · standardAP
2019-12-13Labeling · Supplement 14 · standardAP
2015-06-14Labeling · Supplement 1 · standardAP
2013-12-12UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.