← FDA DRUG APPROVALS

FDA ANDA · ANDA065523

PIPERACILLIN AND TAZOBACTAM

piperacillin sodium,tazobactam sodium

Sponsor: ISTITUTO BIO ITA SPA

APPLICATION
ANDA065523
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-31
LATEST ACTION
2024-05-01
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

2024-05-01Labeling · Supplement 30 · standardAP
2024-04-12Labeling · Supplement 28 · standardAP
2024-04-12Labeling · Supplement 27 · standardAP
2024-04-05Labeling · Supplement 26 · standardAP
2021-03-16Labeling · Supplement 24 · standardAP
2020-10-14Labeling · Supplement 22 · standardAP
2020-10-14Labeling · Supplement 7 · standardAP
2020-10-14Labeling · Supplement 19 · standardAP
2020-10-14Labeling · Supplement 21 · standardAP
2014-09-17Labeling · Supplement 9 · standardAP
2014-09-09Labeling · Supplement 4AP
2014-09-09Labeling · Supplement 3AP
2011-05-31OriginalAP
VIEW ON DRUGS@FDA ↗

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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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