FdaApplication
ANDA 076709
Identifiers
- fda_app_no: ANDA076709
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2007-08-20 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
4 products