Application 205583
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG BASE | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75239 | SUPPL | 2023-08-22 |
| 75235 | SUPPL | 2023-08-22 |
| 75223 | SUPPL | 2023-08-22 |
| 61237 | SUPPL | 2019-12-11 |
| 61236 | SUPPL | 2019-12-11 |
| 61231 | SUPPL | 2019-12-11 |
| 50900 | SUPPL | 2017-12-27 |
| 50798 | SUPPL | 2017-12-21 |
| 46771 | SUPPL | 2017-01-10 |
| 46714 | SUPPL | 2017-01-06 |
| 44924 | ORIG | 2014-10-10 |
| 22995 | ORIG | 2014-10-10 |
| 40484 | SUPPL | 2014-07-23 |
| 32692 | SUPPL | 2014-07-23 |
| 32691 | SUPPL | 2014-07-23 |
| 19662 | SUPPL | 2014-07-23 |
| 19661 | ORIG | 2014-01-31 |
| 10470 | ORIG | 2014-01-29 |