FdaApplication
ANDA 209655
Identifiers
- fda_app_no: ANDA209655
Properties
| Property | Value |
|---|---|
| applicant_name | ZYDUS PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2023-01-24 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-37 | FENTANYL | 37.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-62 | FENTANYL | 62.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
| FENTANYL-87 | FENTANYL | 87.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL |
8 products