APPLICATION
ANDA203557
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-29
LATEST ACTION
2024-12-03
ROUTE
INTRAVENOUS, PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PIPERACILLIN AND TAZOBACTAMPrescription
PIPERACILLIN SODIUM EQ 36GM BASE/VIAL, TAZOBACTAM SODIUM EQ 4.5GM BASE/VIAL · INJECTABLE · INJECTION
PIPERACILLIN AND TAZOBACTAMPrescription
PIPERACILLIN SODIUM EQ 12GM BASE/VIAL, TAZOBACTAM SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-12-03Labeling · Supplement 36 · standardAP
2024-05-01Labeling · Supplement 35 · standardAP
2024-04-03Labeling · Supplement 27 · standardAP
2024-04-03Labeling · Supplement 28 · standardAP
2021-12-08Labeling · Supplement 24 · standardAP
2021-07-08Labeling · Supplement 22 · standardAP
2019-08-30Labeling · Supplement 17 · standardAP
2019-08-30Labeling · Supplement 11 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 3 · unknownAP
2014-10-29UNKNOWN · Supplement 1 · standardAP
2014-10-29UNKNOWN · OriginalAP
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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