APPLICATION
ANDA090581
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-20
LATEST ACTION
2024-05-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN SODIUMPrescription
AMPICILLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-05-01Labeling · Supplement 5 · standardAP
2019-11-18Labeling · Supplement 3 · standardAP
2018-02-15Labeling · Supplement 2 · standardAP
2015-10-20OriginalAP
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.