FdaApplication
ANDA 214557
Identifiers
- fda_app_no: ANDA214557
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2023-08-23 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL |
2 products