APPLICATION
ANDA065403
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-23
LATEST ACTION
2025-07-23
ROUTE
INTRAVENOUS, 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
2025-07-23Labeling · Supplement 20 · standardAP
2024-09-27Labeling · Supplement 16 · standardAP
2024-09-27Labeling · Supplement 19 · standardAP
2024-09-27Labeling · Supplement 13 · standardAP
2024-09-27Labeling · Supplement 11 · standardAP
2015-11-24Labeling · Supplement 8 · standardAP
2015-11-24Labeling · Supplement 7 · standardAP
2013-02-21Labeling · Supplement 6 · standardAP
2013-02-21Labeling · Supplement 2AP
2009-12-23OriginalAP
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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