# TOFACITINIB CITRATE
> **ANDA216001** · Abbreviated New Drug Application (Generic) · Sponsor: SINOTHERAPEUTICS INC · Approved 2025-09-30
## Drug
- **FDA Application Number:** ANDA216001
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TOFACITINIB CITRATE
- **Generic name:** Tofacitinib Citrate
- **Active ingredients:** TOFACITINIB CITRATE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SINOTHERAPEUTICS INC
- **First approval:** 2025-09-30
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216001)
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