FDA
Difluprednate
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- DIFLUPREDNATE 0.05%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DIFLUPREDNATE 0.05% · EmulsionANDA211776-001 · Prescription
- DIFLUPREDNATE 0.05% · EmulsionANDA212566-001 · Prescription
- DIFLUPREDNATE 0.05% · EmulsionANDA218191-001 · Prescription
- DIFLUPREDNATE 0.05% · EmulsionThis page
- DIFLUPREDNATE 0.05% · EmulsionANDA211526-001 · Prescription
- DIFLUPREDNATE 0.05% · EmulsionANDA214894-001 · Prescription
- DIFLUPREDNATE 0.05% · EmulsionANDA213774-001 · Prescription
- DIFLUPREDNATE 0.05% · EmulsionANDA219441-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA207284.
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
- Difluprednate
- Route
- Eye
- Dosage form
- Emulsion
- Applicant
- Epic Pharma LLC
- Status
- Prescription
- FDA approval
- 14 May 2024
- Application
- ANDA207284-001