FdaApplication
NDA 213491
Identifiers
- fda_app_no: NDA213491
Properties
| Property | Value |
|---|---|
| applicant_name | HORIZON THERAPEUTICS USA INC |
| application_type | NDA |
| approval_date | 2020-02-14 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROCYSBI | CYSTEAMINE BITARTRATE | EQ 300MG BASE/PACKET | GRANULE, DELAYED RELEASE;ORAL |
| PROCYSBI | CYSTEAMINE BITARTRATE | EQ 75MG BASE/PACKET | GRANULE, DELAYED RELEASE;ORAL |
2 products