FdaApplication
ANDA 218645
Identifiers
- fda_app_no: ANDA218645
Properties
| Property | Value |
|---|---|
| applicant_name | AUCTA PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2025-04-29 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | FOR SOLUTION;ORAL |
| ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | FOR SOLUTION;ORAL |
2 products