Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018852
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 05/09/1983 | 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 |
|---|---|---|---|---|---|
| 12/12/2001 | SUPPL-26 | Labeling |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
Label is not available on this site. |
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| 04/25/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/27/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/31/2000 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/21/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/09/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 02/25/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/01/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/11/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 03/09/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/09/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |