Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065446
Company: HOSPIRA INC
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
09/15/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065446s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065446s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/04/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/04/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/04/2017 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/04/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/04/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065446s000lbl.pdf

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 207848 APOLLO PHARMS INC
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 065446 HOSPIRA INC
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 207146 WOCKHARDT BIO AG
ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050684 WYETH PHARMS

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