Composition
- Active ingredients
- KETOTIFEN FUMARATE EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsANDA077200-001 · Over the counter
- KETOTIFEN FUMARATE EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Solution/dropsThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021066.
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
- Zaditor
- Active substance
- ketotifen fumarate
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Alcon Pharma
- Status
- Discontinued
- FDA approval
- 2 Jul 1999
- Application
- NDA021066-002