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FDA ANDA · ANDA065498
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium and tazobactam sodium
Sponsor: EUGIA PHARMA SPECLTS
APPLICATION
ANDA065498
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-23
LATEST ACTION
2024-12-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PIPERACILLIN AND TAZOBACTAMPrescription
PIPERACILLIN SODIUM EQ 4GM BASE/VIAL, TAZOBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
PIPERACILLIN AND TAZOBACTAMPrescription
PIPERACILLIN SODIUM EQ 2GM BASE/VIAL, TAZOBACTAM SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INJECTION
PIPERACILLIN AND TAZOBACTAMPrescription
PIPERACILLIN SODIUM EQ 3GM BASE/VIAL, TAZOBACTAM SODIUM EQ 375MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-12-03Labeling · Supplement 31 · standardAP
2024-05-01Labeling · Supplement 26 · standardAP
2023-10-13Manufacturing (CMC) · Supplement 22 · unknownAP
2022-01-31Labeling · Supplement 19 · standardAP
2021-03-16Labeling · Supplement 18 · standardAP
2019-08-29Labeling · Supplement 14 · standardAP
2019-08-29Labeling · Supplement 9 · standardAP
2016-05-23Labeling · Supplement 3AP
2016-05-23Labeling · Supplement 6 · standardAP
2016-05-23Labeling · Supplement 4 · standardAP
2011-05-23OriginalAP
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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