FdaApplication
NDA 217186
Identifiers
- fda_app_no: NDA217186
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES LLC |
| application_type | NDA |
| approval_date | 2024-08-07 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CREXONT | CARBIDOPA; LEVODOPA | 35MG;140MG | CAPSULE, EXTENDED RELEASE;ORAL |
| CREXONT | CARBIDOPA; LEVODOPA | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE;ORAL |
| CREXONT | CARBIDOPA; LEVODOPA | 70MG;280MG | CAPSULE, EXTENDED RELEASE;ORAL |
| CREXONT | CARBIDOPA; LEVODOPA | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE;ORAL |
4 products