Orange Book product · Generic (ANDA)
TOFACITINIB CITRATE
TOFACITINIB CITRATE
At a glance
Aug 19, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
TOFACITINIB CITRATE
Strength
EQ 11MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 219542
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TOFACITINIB CITRATE
- 2020XELJANZBrand (NDA)
NDA 213082 · PFIZER
- 2016XELJANZ XRBrand (NDA)
NDA 208246 · PFIZER
- 2012XELJANZBrand (NDA)
NDA 203214 · PF PRISM CV
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 219370 · AUSON
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 218900 · SAPTALIS PHARMS
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 219830 · ORIENT PHARMA
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 218821 · CONCORD BIOTECH LTD
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 215552 · YAOPHARMA CO LTD
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 217298 · MSN
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 218407 · SUN PHARM INDS INC
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 220458 · APOTEX
- 2026TOFACITINIB CITRATEGeneric (ANDA)
ANDA 218096 · APOTEX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
