Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062750
Company: WYETH PHARMS INC
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 | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PIPRACIL | PIPERACILLIN SODIUM | EQ 3GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PIPRACIL | PIPERACILLIN SODIUM | EQ 4GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/13/1987 | 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 |
|---|---|---|---|---|---|
| 10/15/2002 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/25/2002 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/27/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/31/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/31/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 10/12/2001 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 12/27/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/29/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/30/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/21/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/04/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |