FdaApplication
ANDA 209543
Identifiers
- fda_app_no: ANDA209543
Properties
| Property | Value |
|---|---|
| applicant_name | ALEMBIC PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2025-05-23 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BOSUTINIB MONOHYDRATE | BOSUTINIB MONOHYDRATE | EQ 500MG BASE | TABLET;ORAL |
| BOSUTINIB MONOHYDRATE | BOSUTINIB MONOHYDRATE | EQ 100MG BASE | TABLET;ORAL |
2 products