APPLICATION
ANDA065406
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-22
LATEST ACTION
2026-02-17
ROUTE
INTRAVENOUS, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-02-17Labeling · Supplement 13 · standardAP
2026-02-17Labeling · Supplement 11 · standardAP
2026-02-17Labeling · Supplement 8 · standardAP
2026-02-17Labeling · Supplement 16 · standardAP
2026-02-17Labeling · Supplement 20 · standardAP
2026-02-17Labeling · Supplement 19 · standardAP
2026-02-17Labeling · Supplement 21 · standardAP
2013-02-21Labeling · Supplement 7 · standardAP
2009-12-22OriginalAP
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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