FdaApplication
NDA 021400
Identifiers
- fda_app_no: NDA021400
Properties
| Property | Value |
|---|---|
| applicant_name | BAYER HEALTHCARE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2003-08-19 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LEVITRA | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products