Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050545
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIPRACIL PIPERACILLIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PIPRACIL PIPERACILLIN SODIUM EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PIPRACIL PIPERACILLIN SODIUM EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PIPRACIL PIPERACILLIN SODIUM EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/29/1981 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2008 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050545s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050545s053ltr.pdf
07/27/2005 SUPPL-52 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf
07/27/2005 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf
04/02/2004 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50545slr050ltr.pdf
12/02/2002 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/2002 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2002 SUPPL-42 Labeling

Label is not available on this site.

08/20/2001 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/22/2003 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf
11/22/2000 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/13/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/22/2003 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf
05/22/2003 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf
09/20/1991 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1989 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1988 SUPPL-27 Labeling

Label is not available on this site.

05/03/1988 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/22/1987 SUPPL-25 Labeling

Label is not available on this site.

09/25/1987 SUPPL-24 Labeling

Label is not available on this site.

07/22/1987 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/06/1987 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1987 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1987 SUPPL-20 Labeling

Label is not available on this site.

03/30/1989 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/15/1986 SUPPL-18 Labeling

Label is not available on this site.

09/30/1985 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/03/1985 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1985 SUPPL-14 Labeling

Label is not available on this site.

05/31/1985 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1984 SUPPL-11 Labeling

Label is not available on this site.

08/01/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/06/1984 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

07/05/1983 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1984 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2008 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050545s053lbl.pdf

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