FdaApplication
ANDA 207681
Identifiers
- fda_app_no: ANDA207681
Properties
| Property | Value |
|---|---|
| applicant_name | ALEMBIC PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2017-12-08 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
2 products