FDA
Ketotifen Fumarate
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- KETOTIFEN FUMARATE EQ 0.025% BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsANDA077958-001 · Over the counter
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsThis page
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsANDA204059-001 · Over the counter
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA077354.
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
- Ketotifen Fumarate
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Apotex Inc
- Status
- Discontinued
- FDA approval
- 9 May 2006
- Application
- ANDA077354-001