Application 203388
- Type
- NDA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERIVEDGE | VISMODEGIB | CAPSULE;ORAL | 150MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-140 | ERIVEDGE | vismodegib | Genentech, Inc. | NDA | Current |
| 50242-140 | ERIVEDGE | vismodegib | Genentech, Inc. | NDA | Current |
| 50242-140 | ERIVEDGE | vismodegib | Genentech, Inc. | NDA | Current |
| 50242-140 | ERIVEDGE | vismodegib | Genentech, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73898 | SUPPL | 2023-03-28 |
| 73897 | SUPPL | 2023-03-28 |
| 73890 | SUPPL | 2023-03-28 |
| 64189 | SUPPL | 2020-08-03 |
| 64188 | SUPPL | 2020-08-03 |
| 64171 | SUPPL | 2020-08-03 |
| 58128 | SUPPL | 2019-03-28 |
| 58083 | SUPPL | 2019-03-27 |
| 58082 | SUPPL | 2019-03-27 |
| 57297 | SUPPL | 2019-01-22 |
| 57284 | SUPPL | 2019-01-22 |
| 57283 | SUPPL | 2019-01-22 |
| 49242 | SUPPL | 2017-08-04 |
| 49236 | SUPPL | 2017-08-04 |
| 49235 | SUPPL | 2017-08-04 |
| 45797 | SUPPL | 2016-11-08 |
| 45809 | SUPPL | 2016-11-04 |
| 40291 | SUPPL | 2015-05-27 |
| 40290 | SUPPL | 2015-05-27 |
| 19463 | SUPPL | 2015-05-27 |
| 19462 | SUPPL | 2015-05-27 |
| 32419 | SUPPL | 2015-05-22 |
| 32418 | SUPPL | 2015-05-22 |
| 10205 | SUPPL | 2015-05-22 |
| 10204 | SUPPL | 2015-05-22 |
| 22922 | ORIG | 2012-03-02 |
| 10203 | ORIG | 2012-01-31 |
| 19461 | ORIG | 2012-01-30 |