FDA ANDA · ANDA201024
AMPICILLIN SODIUM AND SULBACTAM SODIUM
ampicillin sodium, sulbactam sodium
Sponsor: ONESOURCE SPECIALTY
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APPLICATION
ANDA201024
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-07
LATEST ACTION
2026-10-19
ROUTE
INTRAMUSCULAR, INTRAVENOUS, 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
2026-10-19Labeling · Supplement 17 · standardAP
2026-10-19Labeling · Supplement 16 · standardAP
2026-10-19Labeling · Supplement 8 · standardAP
2026-10-19Labeling · Supplement 14 · standardAP
2020-04-19Labeling · Supplement 3 · standardAP
2020-04-19Labeling · Supplement 4 · standardAP
2016-02-17Labeling · Supplement 1 · standardAP
2014-04-07Not Applicable · OriginalAP
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