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 | Prescription | AB | No | No |
| SEPTRA DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1973 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/15/2020 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s065lbl.pdf | |
| 08/10/2020 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s063,s064ltr.pdf | |
| 08/10/2020 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s063,s064ltr.pdf | |
| 11/18/2020 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s062ltr.pdf | |
| 02/01/2018 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017376s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017376Orig1s061ltr.pdf | |
| 08/30/2013 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017376Orig1s060ltr.pdf |
| 09/10/2007 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf | |
| 03/11/2008 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf | |
| 07/28/2005 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf | |
| 10/04/2000 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/31/2000 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1997 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 04/07/1998 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1992 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/15/1990 | SUPPL-41 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/09/1990 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/09/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1987 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 01/16/1985 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1985 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1983 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1982 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/01/1984 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/27/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/03/1981 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1981 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1980 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/09/1980 | SUPPL-25 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/28/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1978 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1979 | SUPPL-21 | Efficacy |
Label is not available on this site. |
||
| 07/05/1977 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/21/1977 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-17 | Efficacy |
Label is not available on this site. |
||
| 11/22/1976 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/1976 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/07/1977 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/27/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/12/1976 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/25/1974 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1974 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/01/1974 | SUPPL-3 |
Label is not available on this site. |
|||
| 10/08/1974 | SUPPL-2 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
SEPTRA
TABLET;ORAL; 400MG;80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 017377 | SUN PHARM INDUSTRIES |
| SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 017376 | MONARCH PHARMS |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 076899 | AMNEAL PHARMS NY |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 090624 | AUROBINDO PHARMA |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 078060 | CHARTWELL MOLECULES |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 090828 | GLENMARK PHARMS LTD |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 071017 | SUN PHARM INDUSTRIES |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | No | AB | 076817 | VISTA PHARMS |
SEPTRA DS
TABLET;ORAL; 800MG;160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACTRIM DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 017377 | SUN PHARM INDUSTRIES |
| SEPTRA DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 017376 | MONARCH PHARMS |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 076899 | AMNEAL PHARMS NY |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 090624 | AUROBINDO PHARMA |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 078060 | CHARTWELL MOLECULES |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 090828 | GLENMARK PHARMS LTD |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 071017 | SUN PHARM INDUSTRIES |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | No | AB | 076817 | VISTA PHARMS |