FdaApplication
NDA 209311
Identifiers
- fda_app_no: NDA209311
Properties
| Property | Value |
|---|---|
| applicant_name | IRONSHORE PHARMACEUTICALS INC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC |
| application_type | NDA |
| approval_date | 2018-08-08 |
Revenue by product
JORNAY PM
| Period | Revenue |
|---|---|
| Q2 2026 | $46.1M |
| Q1 2026 | $38.9M |
| Q4 2025 | $45.9M |
| Q3 2025 | $41.8M |
| Q2 2025 | $32.6M |
| Q1 2025 | $28.5M |
| Q4 2024 | $29.3M |
| Q3 2024 | $8.0M |
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 (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| JORNAY PM | METHYLPHENIDATE HYDROCHLORIDE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL |
| JORNAY PM | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL |
| JORNAY PM | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL |
| JORNAY PM | METHYLPHENIDATE HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL |
| JORNAY PM | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL |
5 products