Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | Yes | No |
| BACTRIM PEDIATRIC | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/15/1975 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017560s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017560Orig1s045ltr.pdf | |
| 07/28/2020 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017560s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017560Orig1s044ltr.pdf | |
| 11/09/2001 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1990 | SUPPL-39 | Efficacy-New Indication |
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. |
||
| 06/04/1987 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/11/1987 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 06/10/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1985 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/12/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1984 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1982 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/09/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1980 | SUPPL-20 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/31/1980 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/23/1982 | SUPPL-18 | Efficacy |
Label is not available on this site. |
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| 12/17/1979 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/17/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/07/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/17/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/07/1979 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/27/1979 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 11/14/1977 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/21/1977 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/11/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/01/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/23/1976 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/27/1976 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/21/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017560s045lbl.pdf | |
| 07/28/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017560s044lbl.pdf |