Application 209577
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BOSUTINIB | BOSUTINIB MONOHYDRATE | TABLET;FILM COATED | 400MG | No | No |
| 002 | BOSUTINIB | BOSUTINIB MONOHYDRATE | TABLET;FILM COATED | EQ 100MG BASE | No | No |
| 003 | BOSUTINIB | BOSUTINIB MONOHYDRATE | TABLET;FILM COATED | EQ 500MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58808 | ORIG | 2019-05-21 |