Application 201917
- Type
- NDA
- Sponsor
- VERTEX PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INCIVEK | TELAPREVIR | TABLET;ORAL | 375MG | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 32146 | SUPPL | 2013-10-29 |
| 9938 | SUPPL | 2013-10-29 |
| 40091 | SUPPL | 2013-10-28 |
| 19041 | SUPPL | 2013-10-28 |
| 32145 | SUPPL | 2013-04-30 |
| 19040 | SUPPL | 2013-04-29 |
| 23955 | ORIG | 2012-12-27 |
| 9937 | SUPPL | 2012-12-19 |
| 19039 | SUPPL | 2012-12-17 |
| 19038 | SUPPL | 2012-06-26 |
| 32144 | SUPPL | 2012-06-25 |
| 9936 | SUPPL | 2012-03-26 |
| 40090 | SUPPL | 2012-03-23 |
| 43376 | ORIG | 2011-07-08 |
| 24403 | ORIG | 2011-07-08 |
| 32143 | ORIG | 2011-05-23 |
| 23481 | ORIG | 2011-05-23 |
| 23057 | ORIG | 2011-05-23 |
| 19037 | ORIG | 2011-05-23 |