Application 017376
- Type
- NDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | TABLET;ORAL | 400MG;80MG | No | No |
| 002 | SEPTRA DS | SULFAMETHOXAZOLE; TRIMETHOPRIM | TABLET;ORAL | 800MG;160MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81348 | SUPPL | 2025-02-25 |
| 81325 | SUPPL | 2025-02-24 |
| 78891 | SUPPL | 2024-06-25 |
| 78887 | SUPPL | 2024-06-25 |
| 65287 | SUPPL | 2020-11-19 |
| 65277 | SUPPL | 2020-11-19 |
| 64264 | SUPPL | 2020-08-11 |
| 64262 | SUPPL | 2020-08-11 |
| 64257 | SUPPL | 2020-08-11 |
| 64256 | SUPPL | 2020-08-11 |
| 63964 | ORIG | 2020-07-20 |
| 63939 | SUPPL | 2020-07-16 |
| 52294 | SUPPL | 2018-02-02 |
| 52237 | SUPPL | 2018-02-01 |
| 33246 | SUPPL | 2013-09-09 |
| 13113 | SUPPL | 2013-09-05 |
| 33244 | SUPPL | 2008-03-13 |
| 13112 | SUPPL | 2008-03-13 |
| 566 | SUPPL | 2007-09-25 |
| 33245 | SUPPL | 2007-09-11 |
| 33243 | SUPPL | 2005-08-03 |
| 565 | SUPPL | 2005-08-03 |