Application 202429
- Type
- NDA
- Sponsor
- HOFFMANN LA ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZELBORAF | VEMURAFENIB | TABLET;ORAL | 240MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-090 | ZELBORAF | Vemurafenib | Genentech, Inc. | NDA | Current |
| 50242-090 | ZELBORAF | Vemurafenib | Genentech, Inc. | NDA | Current |
| 50242-090 | ZELBORAF | Vemurafenib | Genentech, Inc. | NDA | Current |
| 50242-090 | ZELBORAF | Vemurafenib | Genentech, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63336 | SUPPL | 2020-05-29 |
| 63096 | SUPPL | 2020-05-19 |
| 54732 | SUPPL | 2018-07-02 |
| 50355 | SUPPL | 2017-11-09 |
| 50293 | SUPPL | 2017-11-06 |
| 50292 | SUPPL | 2017-11-06 |
| 49805 | SUPPL | 2017-09-19 |
| 49804 | SUPPL | 2017-09-19 |
| 48062 | SUPPL | 2017-04-18 |
| 48055 | SUPPL | 2017-04-18 |
| 45192 | SUPPL | 2016-08-31 |
| 45161 | SUPPL | 2016-08-31 |
| 19347 | SUPPL | 2016-05-11 |
| 10048 | SUPPL | 2016-05-11 |
| 40183 | SUPPL | 2015-08-12 |
| 32258 | SUPPL | 2015-08-12 |
| 40182 | SUPPL | 2014-12-03 |
| 10047 | SUPPL | 2014-11-28 |
| 32257 | SUPPL | 2014-03-20 |
| 19345 | SUPPL | 2014-03-20 |
| 10046 | SUPPL | 2014-02-11 |
| 19346 | SUPPL | 2014-02-07 |
| 40181 | SUPPL | 2013-07-05 |
| 32256 | SUPPL | 2013-07-05 |
| 19344 | SUPPL | 2013-07-05 |
| 10045 | SUPPL | 2013-07-05 |
| 43401 | ORIG | 2011-10-21 |
| 40180 | ORIG | 2011-08-17 |
| 32255 | ORIG | 2011-08-17 |
| 24417 | ORIG | 2011-08-17 |