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Application 218390
- Type
- NDA
- Sponsor
- NEUROCRINE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 40MG BASE | Yes | No |
| 002 | INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 60MG BASE | Yes | No |
| 003 | INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 80MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85661 | SUPPL | 2026-04-09 |
| 82127 | ORIG | 2025-05-01 |
| 78329 | ORIG | 2024-07-23 |
| 78343 | ORIG | 2024-05-02 |
| 78330 | ORIG | 2024-05-01 |