FdaApplication
ANDA 205550
Identifiers
- fda_app_no: ANDA205550
Properties
| Property | Value |
|---|---|
| applicant_name | JUBILANT GENERICS LTD |
| application_type | ANDA |
| approval_date | 2016-10-12 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE;ORAL |
2 products