Drugs@FDA: FDA-Approved Drugs
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 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | 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 |
---|---|---|---|---|---|---|---|
05/19/1982 | 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 |
---|---|---|---|---|---|
06/24/2024 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018598s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018598Orig1s055ltr.pdf | |
10/15/2021 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018598s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018598Orig1s054ltr.pdf | |
09/05/2019 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018598s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018598Orig1s052ltr.pdf | |
02/03/2011 | SUPPL-51 | Labeling-Package Insert |
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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02/20/2008 | SUPPL-50 | Labeling |
Label is not available on this site. |
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06/23/2000 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/02/2000 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/07/1998 | SUPPL-36 | Labeling |
Label is not available on this site. |
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07/11/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
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10/08/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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10/08/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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05/03/1996 | SUPPL-32 | Labeling |
Label is not available on this site. |
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05/03/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/09/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
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07/28/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
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10/20/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/20/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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03/08/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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11/07/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
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03/27/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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01/13/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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08/18/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/07/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/29/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/24/2024 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018598s055lbl.pdf | |
10/15/2021 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018598s054lbl.pdf | |
09/05/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018598s052lbl.pdf |