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FDA ANDA · ANDA065222
AMPICILLIN AND SULBACTAM
ampicillin sodium and sulbactam sodium
Sponsor: ISTITUTO BIO ITA SPA
APPLICATION
ANDA065222
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-29
LATEST ACTION
2026-03-03
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
2026-03-03Labeling · Supplement 18 · standardAP
2026-03-03Labeling · Supplement 22 · standardAP
2026-03-03Labeling · Supplement 14 · standardAP
2026-03-03Labeling · Supplement 20 · standardAP
2005-11-29OriginalAP
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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