# KETOTIFEN FUMARATE
> **ANDA077354** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2006-05-09
## Drug
- **FDA Application Number:** ANDA077354
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** KETOTIFEN FUMARATE
- **Generic name:** Ketotifen Fumarate
- **Active ingredients:** KETOTIFEN FUMARATE
- **Dosage form:** SOLUTION/DROPS
- **Route:** OPHTHALMIC
- **Marketing status:** Discontinued
- **Sponsor:** APOTEX INC
- **First approval:** 2006-05-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077354)
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