Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017376
Company: MONARCH PHARMS
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
| SEPTRA DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2025 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017376s068lbl.pdf | |
| 06/24/2024 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017376s066lbl.pdf | |
| 11/18/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s062lbl.pdf | |
| 08/10/2020 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf | |
| 08/10/2020 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf | |
| 07/15/2020 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s065lbl.pdf | |
| 02/01/2018 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017376s061lbl.pdf | |
| 08/30/2013 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017376s060lbl.pdf |
| 03/11/2008 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf | |
| 09/10/2007 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf | |
| 07/28/2005 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf |