FDA.reportPublic FDA data

Application 209923

Type
ANDA
Sponsor
PRINSTON PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOFACITINIBTOFACITINIBTABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tofacitinibTOFACITINIBZydus Lifesciences Limitedf4d0e580-74a8-496e-89a2-d74478c946bf2026-05-29Name fallback
brand name: tofacitinib
generic name: TOFACITINIB
TofacitinibTOFACITINIB CITRATEBreckenridge Pharmaceutical, Inc.c963c610-52e5-43ab-aac6-3f7e5341b7642026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
tofacitinibTOFACITINIBZydus Lifesciences Limitedac0b26d5-1352-42ff-b5ea-3eb02d8508a42026-05-12Name fallback
brand name: tofacitinib
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBExelan pharmaceuticals,Ince68680e5-0328-4e66-b8bb-4af126221ec72026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
Tofacitinib XRTOFACITINIBBiocon Pharma Incf0160e3d-63ea-75fb-4b88-fe3d6a6ce0302026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55953ORIG2018-10-17