Application 207922
- Type
- ANDA
- Sponsor
- BRECKENRIDGE PHARMS
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 | 110MG | No | No |
| 003 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | 150MG | No | No |