Skip to contentApplication 214927
- Type
- NDA
- Sponsor
- ZEVRA DENMARK
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIPLYFFA | ARIMOCLOMOL CITRATE | CAPSULE;ORAL | EQ 47MG BASE | Yes | No |
| 002 | MIPLYFFA | ARIMOCLOMOL CITRATE | CAPSULE;ORAL | EQ 62MG BASE | Yes | No |
| 003 | MIPLYFFA | ARIMOCLOMOL CITRATE | CAPSULE;ORAL | EQ 93MG BASE | Yes | No |
| 004 | MIPLYFFA | ARIMOCLOMOL CITRATE | CAPSULE;ORAL | EQ 124MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80001 | ORIG | 2024-10-28 |
| 79720 | ORIG | 2024-09-24 |
| 79662 | ORIG | 2024-09-20 |