Application 214264

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOFACITINIBTOFACITINIB CITRATETABLET, EXTENDED RELEASE;ORALEQ 11MG BASENoNo
002TOFACITINIBTOFACITINIB CITRATETABLET, EXTENDED RELEASE;ORALEQ 22MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214264-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19
A214264-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214264-001AB
A214264-002AB

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
2026-08-01 22:54:322026-06A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19a50c72e98297…
2026-08-01 22:54:322026-06A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214264-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214264-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tofacitinibTOFACITINIBZydus Lifesciences Limitedac0b26d5-1352-42ff-b5ea-3eb02d8508a42026-05-12Exact identifier
application applno (ANDA): 214264
application number: ANDA214264
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214264
application number: ANDA214264

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68526ORIG2021-09-02