FdaApplication
NDA 021956
Identifiers
- fda_app_no: NDA021956
Properties
| Property | Value |
|---|---|
| applicant_name | CONCORDIA PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2006-08-28 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DUTOPROL | HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE | 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| DUTOPROL | HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE | 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| DUTOPROL | HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE | 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
3 products