# LEFLUNOMIDE
> **ANDA091369** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2011-11-21
## Drug
- **FDA Application Number:** ANDA091369
- **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:** ALEMBIC PHARMS LTD
- **Manufacturer:** Alembic Pharmaceuticals Limited
- **First approval:** 2011-11-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091369)
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*MORVS · CC0 1.0*