APPLICATION
ANDA201406
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-07
LATEST ACTION
2024-09-27
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-27Labeling · Supplement 1 · standardAP
2024-09-27Labeling · Supplement 7 · standardAP
2024-09-27Labeling · Supplement 3 · standardAP
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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