# KETOTIFEN FUMARATE
> **ANDA204059** · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2020-06-01
## Drug
- **FDA Application Number:** ANDA204059
- **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:** Over-the-counter
- **Sponsor:** UNICHEM
- **Manufacturer:** Unichem Pharmaceuticals (USA), Inc.
- **First approval:** 2020-06-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204059)
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