Drugs@FDA: FDA-Approved Drugs
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/10/1985 | 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 |
|---|---|---|---|---|---|
| 05/29/2001 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/27/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/07/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/17/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1998 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 10/22/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/07/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/16/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/14/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/28/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/27/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |