Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070889
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/13/1986 | 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 |
|---|---|---|---|---|---|
| 01/30/2023 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/25/2014 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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| 04/17/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/28/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/17/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/27/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/23/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |