Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207848
Company: PROVEPHARM SAS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
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
05/11/2018 ORIG-2 Approval STANDARD

Label is not available on this site.
01/13/2017 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

PIPERACILLIN AND TAZOBACTAM

INJECTABLE;INJECTION; EQ 12GM BASE/VIAL;EQ 1.5GM 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 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206204 FRESENIUS KABI USA
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207848 PROVEPHARM SAS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203557 SANDOZ INC

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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