Application 213137
- Type
- NDA
- Sponsor
- GLOBAL BLOOD THERAPS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXBRYTA | VOXELOTOR | TABLET;ORAL | 500MG | Yes | Yes |
| 002 | OXBRYTA | VOXELOTOR | TABLET;ORAL | 300MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-101 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-102 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75258 | SUPPL | 2023-08-22 |
| 75147 | SUPPL | 2023-08-21 |
| 69736 | SUPPL | 2021-12-22 |
| 69621 | SUPPL | 2021-12-17 |
| 61373 | ORIG | 2019-12-23 |
| 61062 | ORIG | 2019-11-26 |
| 61047 | ORIG | 2019-11-25 |