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 1 of 1 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBNovadoz Pharmaceuticals LLC327f6b60-1a5d-49e6-acff-18603d0ee9d02026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
TofacitinibTOFACITINIBEdenbridge Pharmaceuticals LLC.576722e5-6639-452d-a5c3-33a064f194812026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TofacitinibTOFACITINIBGolden State Medical Supply, Inc.58f22c41-87d2-e745-e063-6394a90a962e2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tofacitinib
generic name: TOFACITINIB
TofacitinibTOFACITINIBMacleods Pharmaceuticals Limited9b654f0d-7705-4880-9e9d-ad3a51e56b562026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TofacitinibTOFACITINIBApotex Corp.7d4f5cfa-35a8-1458-a609-f6b417946abb2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBAurobindo Pharma Limitede54b186f-e42a-4477-939c-8dd331045fbe2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBAurobindo Pharma Limited50962b08-99dd-ae73-e063-6394a90ad1eb2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBIPG Pharmaceuticals, Inccd1b61bf-de03-4198-89f6-f3952b79d2c22026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
tofacitinib solutionTOFACITINIBHikma Pharmaceuticals USA Inc.d9cf18a9-e825-49ac-b080-68957c0e79ae2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBOrient Pharma Co., Ltd. Yunlin Plant5617a652-a78e-74b1-e063-6394a90a31c72026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
TofacitinibTOFACITINIBAvKARE5502f252-2b39-2cfd-e063-6394a90a8a482026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TofacitinibTOFACITINIBAjanta Pharma USA Inc.024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBSomerset Therapeutics, LLC2726c2b0-c763-4635-ac6b-4334c3a5a8bc2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
generic name: TOFACITINIB
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

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