Application 212306
- Type
- NDA
- Sponsor
- KARYOPHARM THERAPS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XPOVIO | SELINEXOR | TABLET;ORAL | 20MG | Yes | Yes |
| 002 | XPOVIO | SELINEXOR | TABLET;ORAL | 40MG | Yes | No |
| 003 | XPOVIO | SELINEXOR | TABLET;ORAL | 50MG | Yes | No |
| 004 | XPOVIO | SELINEXOR | TABLET;ORAL | 60MG | Yes | No |
| 005 | XPOVIO | SELINEXOR | TABLET;ORAL | 10MG | Yes | No |
| 006 | XPOVIO | SELINEXOR | TABLET;ORAL | 80MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-101 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-102 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-102 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-102 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-102 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-103 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-103 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-103 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-103 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-104 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-104 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-104 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |
| 72237-104 | XPOVIO | selinexor | Karyopharm Therapeutics Inc. | NDA | Current |