Generic Companies with Tentative Approvals for: dabigatran etexilate mesylate
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dabigatran etexilate mesylate Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
Alembic Pharms Ltd | dabigatran etexilate mesylate | 215233 | EQ 150MG BASE | CAPSULE;ORAL |
Dr Reddys Labs Ltd | dabigatran etexilate mesylate | 208048 | EQ 110MG BASE | CAPSULE;ORAL |
Teva Pharms Usa | dabigatran etexilate mesylate | 208057 | EQ 150MG BASE | CAPSULE;ORAL |
Alembic Pharms Ltd | dabigatran etexilate mesylate | 208046 | EQ 150MG BASE | CAPSULE;ORAL |
Breckenridge Pharms | dabigatran etexilate mesylate | 207922 | 110MG | CAPSULE;ORAL |
Alembic Pharms Ltd | dabigatran etexilate mesylate | 215233 | EQ 110MG BASE | CAPSULE;ORAL |
Teva Pharms Usa | dabigatran etexilate mesylate | 208057 | EQ 110MG BASE | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |