Application 214302
- Type
- ANDA
- Sponsor
- ZYDUS WORLDWIDE DMCC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 0.2MG | No | No |
| 002 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 400MCG | No | No |
| 003 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 600MCG | No | No |
| 004 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 800MCG | No | No |
| 005 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1000MC | No | No |
| 006 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1200MCG | No | No |
| 007 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1400MCG | No | No |
| 008 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1600MCG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73131 | ORIG | 2023-01-10 |
| 71880 | ORIG | 2022-08-25 |