APPLICATION
ANDA065176
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-30
LATEST ACTION
2026-01-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-01-19Labeling · Supplement 24 · standardAP
2026-01-19Labeling · Supplement 20 · standardAP
2019-11-16Labeling · Supplement 14 · standardAP
2015-05-01Labeling · Supplement 10 · standardAP
2008-08-05Labeling · Supplement 4AP
2007-07-16Labeling · Supplement 3AP
2005-11-30OriginalAP
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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