FdaApplication
NDA 212994
Identifiers
- fda_app_no: NDA212994
Properties
| Property | Value |
|---|---|
| applicant_name | COMMAVE SUB LLC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC |
| application_type | NDA |
| approval_date | 2021-05-07 |
Revenue by product
AZSTARYS
| Period | Revenue |
|---|---|
| Q2 2026 | $12.9M* |
| Q2 2025 | $0.0M* |
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.
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AZSTARYS | DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE | EQ 5.2MG BASE;EQ 26.1MG BASE | CAPSULE;ORAL |
| AZSTARYS | DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE | EQ 7.8MG BASE;EQ 39.2MG BASE | CAPSULE;ORAL |
| AZSTARYS | DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE | EQ 10.4MG BASE;EQ 52.3MG BASE | CAPSULE;ORAL |
3 products