# LEFLUNOMIDE
> **ANDA077090** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2005-09-13
## Drug
- **FDA Application Number:** ANDA077090
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LEFLUNOMIDE
- **Generic name:** LEFLUNOMIDE
- **Active ingredients:** LEFLUNOMIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** APOTEX
- **Manufacturer:** Apotex Corp.
- **First approval:** 2005-09-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077090)
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