FdaApplication
NDA 214927
Identifiers
- fda_app_no: NDA214927
Properties
| Property | Value |
|---|---|
| applicant_name | ZEVRA DENMARK AS |
| application_type | NDA |
| approval_date | 2024-09-20 |
Revenue by product
MIPLYFFA
| Period | Revenue |
|---|---|
| Q2 2026 | $30.2M |
| Q1 2026 | $24.6M |
| Q4 2025 | $26.4M |
| Q3 2025 | $22.4M |
| Q2 2025 | $21.5M |
| Q1 2025 | $17.1M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MIPLYFFA | ARIMOCLOMOL CITRATE | EQ 47MG BASE | CAPSULE;ORAL |
| MIPLYFFA | ARIMOCLOMOL CITRATE | EQ 62MG BASE | CAPSULE;ORAL |
| MIPLYFFA | ARIMOCLOMOL CITRATE | EQ 93MG BASE | CAPSULE;ORAL |
| MIPLYFFA | ARIMOCLOMOL CITRATE | EQ 124MG BASE | CAPSULE;ORAL |
4 products