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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090498
Company: ISTITUTO BIO ITA SPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/31/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2020 SUPPL-17 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/29/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/09/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

PIPERACILLIN AND TAZOBACTAM

INJECTABLE;INJECTION; EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203720 FRESENIUS KABI
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090498 ISTITUTO BIO ITA SPA
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207848 PROVEPHARM SAS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 208675 SAGENT PHARMS INC
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203557 SANDOZ INC
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207146 WOCKHARDT BIO AG
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