Application 202258
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VICTRELIS | BOCEPREVIR | CAPSULE;ORAL | 200MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47070 | SUPPL | 2017-01-31 |
| 47064 | SUPPL | 2017-01-30 |
| 40152 | SUPPL | 2014-07-29 |
| 32219 | SUPPL | 2014-07-29 |
| 19304 | SUPPL | 2014-04-10 |
| 10004 | SUPPL | 2014-04-10 |
| 10006 | SUPPL | 2014-02-26 |
| 19306 | SUPPL | 2014-02-25 |
| 10005 | SUPPL | 2014-02-11 |
| 40151 | SUPPL | 2014-02-10 |
| 19305 | SUPPL | 2014-01-22 |
| 32218 | SUPPL | 2014-01-21 |
| 40150 | SUPPL | 2013-09-19 |
| 10003 | SUPPL | 2013-09-19 |
| 40148 | SUPPL | 2013-03-01 |
| 10001 | SUPPL | 2013-03-01 |
| 19303 | SUPPL | 2013-02-20 |
| 10002 | SUPPL | 2013-02-20 |
| 10000 | SUPPL | 2013-02-15 |
| 40147 | SUPPL | 2013-02-14 |
| 19302 | SUPPL | 2012-12-28 |
| 32217 | SUPPL | 2012-12-26 |
| 40149 | SUPPL | 2012-11-28 |
| 32216 | SUPPL | 2012-11-06 |
| 9998 | SUPPL | 2012-08-01 |
| 40145 | SUPPL | 2012-07-30 |
| 40146 | SUPPL | 2012-04-24 |
| 9999 | SUPPL | 2012-04-24 |
| 44430 | ORIG | 2012-02-13 |
| 44850 | ORIG | 2011-06-15 |
| 43391 | ORIG | 2011-06-15 |
| 23486 | ORIG | 2011-05-17 |
| 43557 | ORIG | 2011-05-13 |
| 40144 | ORIG | 2011-05-13 |
| 9997 | ORIG | 2011-05-13 |