Orange Book product · Generic (ANDA)
TOFACITINIB CITRATE
TOFACITINIB CITRATE
At a glance
Sep 25, 2023
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2023
2 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
TOFACITINIB CITRATE
Strength
EQ 1MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 216878
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.
