Application 216157
- 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 SUSPENSION | 300MG | No | No |
| 002 | OXBRYTA | VOXELOTOR | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72786-111 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
| 72786-111 | OXBRYTA | Voxelotor | Global Blood Therapeutics Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75259 | SUPPL | 2023-08-22 |
| 75148 | SUPPL | 2023-08-21 |
| 71544 | ORIG | 2022-07-14 |
| 69628 | ORIG | 2021-12-19 |
| 69739 | ORIG | 2021-12-15 |