Composition
- Active ingredients
- REVEFENACIN 88UG/3ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- REVEFENACIN 88UG/3ML · SolutionThis page
- REVEFENACIN 175MCG/3ML · SolutionANDA218089-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218088.
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
- Revefenacin
- Dosage form
- Solution
- Applicant
- Lupin Inc.
- Status
- Tentative approval
- FDA approval
- 15 May 2026
- Application
- ANDA218088-002