FdaApplication
ANDA 091190
Identifiers
- fda_app_no: ANDA091190
Properties
| Property | Value |
|---|---|
| applicant_name | PH HEALTH LTD |
| application_type | ANDA |
| approval_date | 2015-03-13 |
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