FdaApplication
NDA 022362
Identifiers
- fda_app_no: NDA022362
Properties
| Property | Value |
|---|---|
| applicant_name | COSETTE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2009-10-02 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| WELCHOL | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION;ORAL |
| WELCHOL | COLESEVELAM HYDROCHLORIDE | 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
2 products