FdaApplication
NDA 021743
Identifiers
- fda_app_no: NDA021743
Properties
| Property | Value |
|---|---|
| applicant_name | OSI PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 2004-11-18 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
3 products