FdaApplication
NDA 203389
Identifiers
- fda_app_no: NDA203389
Properties
| Property | Value |
|---|---|
| applicant_name | HORIZON THERAPEUTICS USA INC |
| application_type | NDA |
| approval_date | 2013-04-30 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROCYSBI | CYSTEAMINE BITARTRATE | EQ 75MG BASE | CAPSULE, DELAYED RELEASE;ORAL |
| PROCYSBI | CYSTEAMINE BITARTRATE | EQ 25MG BASE | CAPSULE, DELAYED RELEASE;ORAL |
2 products