FdaApplication
NDA 208780
Identifiers
- fda_app_no: NDA208780
Properties
| Property | Value |
|---|---|
| applicant_name | LEGACY PHARMA INC SEZC |
| application_type | NDA |
| approval_date | 2017-01-11 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ESBRIET | PIRFENIDONE | 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ESBRIET | PIRFENIDONE | 801MG | TABLET;ORAL |
| ESBRIET | PIRFENIDONE | 267MG | TABLET;ORAL |
3 products