Application 208383
- Type
- NDA
- Sponsor
- PORTOLA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BEVYXXA | BETRIXABAN | CAPSULE;ORAL | 40MG | Yes | No |
| 002 | BEVYXXA | BETRIXABAN | CAPSULE;ORAL | 80MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69853-0201 | BEVYXXA | betrixaban | Portola Pharmaceuticals, Inc. | NDA | Current |
| 69853-0201 | BEVYXXA | betrixaban | Portola Pharmaceuticals, | NDA | Current |
| 69853-0201 | BEVYXXA | betrixaban | Portola Pharmaceuticals, Inc. | NDA | Current |
| 69853-0202 | BEVYXXA | betrixaban | Portola Pharmaceuticals, Inc. | NDA | Current |
| 69853-0202 | BEVYXXA | betrixaban | Portola Pharmaceuticals, | NDA | Current |
| 69853-0202 | BEVYXXA | betrixaban | Portola Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64466 | SUPPL | 2020-09-01 |
| 64412 | SUPPL | 2020-08-25 |
| 59386 | SUPPL | 2019-07-19 |
| 59380 | SUPPL | 2019-07-19 |
| 49056 | ORIG | 2017-07-25 |
| 49000 | SUPPL | 2017-07-17 |
| 48997 | SUPPL | 2017-07-17 |
| 48813 | ORIG | 2017-06-23 |
| 48812 | ORIG | 2017-06-23 |
| 48811 | ORIG | 2017-06-23 |