FdaApplication
ANDA 204827
Identifiers
- fda_app_no: ANDA204827
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2015-12-10 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL |
| FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL |
2 products