Drugs@FDA: FDA-Approved Drugs
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PIPRACIL | PIPERACILLIN SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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PIPRACIL | PIPERACILLIN SODIUM | EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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PIPRACIL | PIPERACILLIN SODIUM | EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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| PIPERACILLIN SODIUM | EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |