FdaApplication
ANDA 207922
Identifiers
- fda_app_no: ANDA207922
Properties
| Property | Value |
|---|---|
| applicant_name | BRECKENRIDGE PHARMACEUTICAL INC |
| application_type | ANDA |
| approval_date | 2024-12-19 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE;ORAL |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL |
3 products