# TOFACITINIB
> **ANDA209633** · Abbreviated New Drug Application (Generic) · Sponsor: BRECKENRIDGE PHARMS · Approved 2026-02-19
## Drug
- **FDA Application Number:** ANDA209633
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TOFACITINIB
- **Generic name:** Tofacitinib
- **Active ingredients:** TOFACITINIB
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** BRECKENRIDGE PHARMS
- **First approval:** 2026-02-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209633)
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