APPLICATION
ANDA065240
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-25
LATEST ACTION
2026-01-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 10GM BASE/VIAL, SULBACTAM SODIUM EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-01-27Labeling · Supplement 29 · standardAP
2024-09-27Labeling · Supplement 27 · standardAP
2021-06-21Labeling · Supplement 23 · standardAP
2020-05-14Labeling · Supplement 17 · standardAP
2020-05-14Labeling · Supplement 19 · standardAP
2015-03-01Labeling · Supplement 13 · standardAP
2015-03-01Labeling · Supplement 12 · standardAP
2013-07-31Labeling · Supplement 11 · standardAP
2007-10-31Manufacturing (CMC) · Supplement 3AP
2006-07-25OriginalAP
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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