APPLICATION
ANDA065188
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-25
LATEST ACTION
2020-07-28
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
2020-07-28Manufacturing (CMC) · Supplement 10 · unknownAP
2019-11-16Labeling · Supplement 16 · standardAP
2015-06-01Labeling · Supplement 11 · standardAP
2015-06-01Labeling · Supplement 12 · standardAP
2013-06-28Labeling · Supplement 9 · standardAP
2008-08-05Labeling · Supplement 3AP
2007-07-17Labeling · Supplement 2AP
2005-11-25OriginalAP
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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