Application 215233
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| Document | Submission type | Date |
|---|
| 79392 | ORIG | 2024-08-14 |