FdaApplication
NDA 205065
Identifiers
- fda_app_no: NDA205065
Properties
| Property | Value |
|---|---|
| applicant_name | BIOMARIN PHARMACEUTICAL INC |
| application_type | NDA |
| approval_date | 2013-12-19 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | FOR SOLUTION;ORAL |
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | FOR SOLUTION;ORAL |
2 products