Application 205123
- Type
- NDA
- Sponsor
- JANSSEN PRODS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLYSIO | SIMEPREVIR SODIUM | CAPSULE;ORAL | EQ 150MG BASE | Yes | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 50401 | SUPPL | 2017-11-14 |
| 50382 | SUPPL | 2017-11-13 |
| 48407 | SUPPL | 2017-05-17 |
| 48371 | SUPPL | 2017-05-12 |
| 47249 | SUPPL | 2017-02-16 |
| 47217 | SUPPL | 2017-02-15 |
| 32643 | SUPPL | 2016-05-24 |
| 19627 | SUPPL | 2016-05-23 |
| 19626 | SUPPL | 2016-03-03 |
| 10429 | SUPPL | 2016-03-02 |
| 40452 | SUPPL | 2015-12-10 |
| 40451 | SUPPL | 2015-10-08 |
| 32640 | SUPPL | 2015-10-06 |
| 32639 | SUPPL | 2015-10-06 |
| 22978 | SUPPL | 2015-08-21 |
| 32641 | SUPPL | 2015-04-17 |
| 40453 | SUPPL | 2015-04-16 |
| 40454 | SUPPL | 2015-04-14 |
| 32642 | SUPPL | 2015-04-13 |
| 40450 | SUPPL | 2014-11-07 |
| 32637 | SUPPL | 2014-11-07 |
| 19625 | SUPPL | 2014-09-09 |
| 32638 | SUPPL | 2014-09-08 |
| 24487 | ORIG | 2013-12-24 |
| 22977 | ORIG | 2013-12-24 |
| 32636 | SUPPL | 2013-12-09 |
| 19624 | SUPPL | 2013-12-06 |
| 40449 | ORIG | 2013-11-26 |
| 32635 | ORIG | 2013-11-25 |