APPLICATION
ANDA203323
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-12
LATEST ACTION
2023-02-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE 1G(BASE)/4ML(250MG/ML) · INJECTABLE · INJECTION
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE EQ 250MG BASE/ML · INJECTABLE · INJECTION
AMIKACIN SULFATEPrescription
AMIKACIN SULFATE 500MG(BASE)/ML(250MG/ML) · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 7 · standardAP
2016-05-12UNKNOWN · Original · standardAP
2016-05-12Manufacturing (CMC) · Supplement 12AP
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.