FDA.reportPublic FDA data

Application 219395

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002TOFACITINIBTOFACITINIB CITRATETABLET5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219395-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03
A219395-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219395-001AB
A219395-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219395-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A219395-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219395-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219395-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219395-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219395-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219395-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219395-002AB1a50c72e98297…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOFACITINIBTOFACITINIBGolden State Medical Supply, Inc.58b94979-55ad-839a-e063-6294a90ad8122026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
TofacitinibTOFACITINIBEdenbridge Pharmaceuticals LLC.576722e5-6639-452d-a5c3-33a064f194812026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TofacitinibTOFACITINIBGolden State Medical Supply, Inc.58f22c41-87d2-e745-e063-6394a90a962e2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tofacitinib
TofacitinibTOFACITINIBMacleods Pharmaceuticals Limited9b654f0d-7705-4880-9e9d-ad3a51e56b562026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TofacitinibTOFACITINIBApotex Corp.7d4f5cfa-35a8-1458-a609-f6b417946abb2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TOFACITINIBTOFACITINIBMicro Labs Limitedffa6819b-23a4-478b-8fb7-cc90e8142fc52026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.21a89264-8047-40ac-8b10-fa64610725092026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tofacitinib
TOFACITINIBTOFACITINIBSun Pharmaceutical Industries, Inc.a764a133-b870-4514-bbee-24d43f8cb7fd2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
TofacitinibTOFACITINIBApotex Corp.dd62a2b8-300b-d92b-7b27-a30eaa68fdd32026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TOFACITINIB CITRATETOFACITINIB CITRATERadha Pharmaceuticals, Inc.141ab3eb-982b-4242-89db-6ddce5be0c402026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB CITRATE
TOFACITINIB CITRATETOFACITINIB CITRATEScieGen Pharmaceuticals, INC.11d08738-efa3-4474-8eda-812bc04adfbb2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB CITRATE
TOFACITINIBTOFACITINIBAurobindo Pharma Limitede54b186f-e42a-4477-939c-8dd331045fbe2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
TOFACITINIBTOFACITINIBAurobindo Pharma Limited50962b08-99dd-ae73-e063-6394a90ad1eb2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
TOFACITINIBTOFACITINIBIPG Pharmaceuticals, Inccd1b61bf-de03-4198-89f6-f3952b79d2c22026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
TOFACITINIBTOFACITINIBOrient Pharma Co., Ltd. Yunlin Plant5617a652-a78e-74b1-e063-6394a90a31c72026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOFACITINIB
TofacitinibTOFACITINIBAvKARE5502f252-2b39-2cfd-e063-6394a90a8a482026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib
TofacitinibTOFACITINIBAjanta Pharma USA Inc.024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tofacitinib