Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065498
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG 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
05/23/2011 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
08/29/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/29/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/23/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/23/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/23/2016 SUPPL-3 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

PIPERACILLIN AND TAZOBACTAM

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL;EQ 250MG 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 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207847 APOLLO PHARMS INC
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212287 ASTRAL
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065498 AUROBINDO PHARMA LTD
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203719 FRESENIUS KABI
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065523 ISTITUTO BIO ITA SPA
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065458 MYLAN LABS LTD
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204959 QILU TIANHE
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065362 SANDOZ
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065363 SANDOZ
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206996 WOCKHARDT BIO AG
ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050684 WYETH PHARMS

INJECTABLE;INJECTION; EQ 3GM BASE/VIAL;EQ 375MG 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 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207847 APOLLO PHARMS INC
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212287 ASTRAL
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065498 AUROBINDO PHARMA LTD
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203719 FRESENIUS KABI
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065523 ISTITUTO BIO ITA SPA
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065458 MYLAN LABS LTD
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204959 QILU TIANHE
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065362 SANDOZ
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065363 SANDOZ
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206996 WOCKHARDT BIO AG
ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050684 WYETH PHARMS

INJECTABLE;INJECTION; EQ 4GM BASE/VIAL;EQ 500MG 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 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207847 APOLLO PHARMS INC
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212287 ASTRAL
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065498 AUROBINDO PHARMA LTD
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203719 FRESENIUS KABI
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065523 ISTITUTO BIO ITA SPA
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065458 MYLAN LABS LTD
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204959 QILU TIANHE
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065362 SANDOZ
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065363 SANDOZ
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206996 WOCKHARDT BIO AG
ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050684 WYETH PHARMS

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