FdaApplication
NDA 019813
Identifiers
- fda_app_no: NDA019813
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1990-08-07 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DURAGESIC-100 | FENTANYL | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL |
| DURAGESIC-12 | FENTANYL | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL |
| DURAGESIC-25 | FENTANYL | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL |
| DURAGESIC-37 | FENTANYL | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL |
| DURAGESIC-50 | FENTANYL | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL |
| DURAGESIC-75 | FENTANYL | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL |
6 products