Generic Companies with Tentative Approvals for: Alembic
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Alembic 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 | bosutinib monohydrate | 209543 | EQ 500MG BASE | TABLET;ORAL |
| Alembic Pharms Ltd | iloperidone | 207409 | 6MG | TABLET;ORAL |
| Alembic | bosutinib monohydrate | 209543 | EQ 100MG BASE | TABLET;ORAL |
| Alembic Pharms Ltd | acalabrutinib | 216775 | 100MG | CAPSULE;ORAL |
| Alembic Pharms Ltd | iloperidone | 207409 | 8MG | TABLET;ORAL |
| Alembic Pharms Ltd | dabigatran etexilate mesylate | 208046 | EQ 150MG BASE | CAPSULE;ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
