Application 218645
- Type
- ANDA
- Sponsor
- AUCTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | POWDER;ORAL | 100MG/PACKET | No | No |
| 002 | ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | POWDER;ORAL | 500MG/PACKET | No | No |