FdaApplication
NDA 021164
Identifiers
- fda_app_no: NDA021164
Properties
| Property | Value |
|---|---|
| applicant_name | FABRE KRAMER PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2023-09-22 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE;ORAL |
4 products