Composition
- Active ingredients
- FENTANYL 12.5MCG/HR
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FENTANYL 12.5MCG/HR · Film, extended releaseANDA077154-005 · Prescription
- FENTANYL 12.5MCG/HR · Film, extended releaseANDA077449-005 · Prescription
- FENTANYL 12.5MCG/HR · Film, extended releaseANDA076258-005 · Prescription
- FENTANYL 12.5MCG/HR · Film, extended releaseThis page
- FENTANYL 12.5MCG/HR · Film, extended releaseANDA202097-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209655.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Fentanyl-12
- Active substance
- fentanyl
- Route
- Transdermal
- Dosage form
- Film, extended release
- Applicant
- Zydus Pharms
- Status
- Discontinued
- FDA approval
- 24 Jan 2023
- Application
- ANDA209655-001