Application 208070
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 002 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | EQ 110MG BASE | No | No |
| 003 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77359 | ORIG | 2024-01-31 |