FdaApplication
ANDA 209651
Identifiers
- fda_app_no: ANDA209651
Properties
| Property | Value |
|---|---|
| applicant_name | HETERO LABS LTD UNIT V |
| application_type | ANDA |
| approval_date | 2025-11-19 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL |
| NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL |
| NILOTINIB HYDROCHLORIDE DIHYDRATE | NILOTINIB HYDROCHLORIDE DIHYDRATE | 150MG | CAPSULE |
3 products