Composition
- Active ingredients
- DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DARIFENACIN HYDROBROMIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021513-002 · Discontinued
- DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021513.
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
- Enablex
- Active substance
- darifenacin hydrobromide
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Abbvie
- Status
- Discontinued
- FDA approval
- 22 Dec 2004
- Application
- NDA021513-001