FdaApplication
ANDA 219382
Identifiers
- fda_app_no: ANDA219382
Properties
| Property | Value |
|---|---|
| applicant_name | SOMERSET THERAPEUTICS LLC |
| application_type | ANDA |
| approval_date | 2026-07-06 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET;ORAL |
2 products