U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065498
Company: EUGIA PHARMA SPECLTS
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
01/31/2022 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

03/16/2021 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

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 212287 ASTRAL
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065498 EUGIA PHARMA SPECLTS
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 207847 PROVEPHARM SAS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204959 QILU
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 208674 SAGENT PHARMS INC
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 065458 STERISCIENCE
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206996 WOCKHARDT BIO AG

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 212287 ASTRAL
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065498 EUGIA PHARMA SPECLTS
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 207847 PROVEPHARM SAS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204959 QILU
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 208674 SAGENT PHARMS INC
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 065458 STERISCIENCE
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206996 WOCKHARDT BIO AG

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 212287 ASTRAL
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065498 EUGIA PHARMA SPECLTS
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 207847 PROVEPHARM SAS
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204959 QILU
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 208674 SAGENT PHARMS INC
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 065458 STERISCIENCE
PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206996 WOCKHARDT BIO AG
Back to Top