FdaApplication
NDA 021513
Identifiers
- fda_app_no: NDA021513
Properties
| Property | Value |
|---|---|
| applicant_name | ABBVIE INC |
| application_type | NDA |
| approval_date | 2004-12-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ENABLEX | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| ENABLEX | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products