Application 209829

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOFACITINIB CITRATETOFACITINIB CITRATETABLET;ORALEQ 5MG 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
A209829-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2023-03-13
A209829-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209829-001AB
A209829-002AB

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 22:54:322026-06A209829-001TOFACITINIB CITRATEEQ 5MG BASETABLET / ORALAB2023-03-13a50c72e98297…
2026-08-01 22:54:322026-06A209829-002TOFACITINIB CITRATEEQ 10MG BASETABLET / ORALAB2026-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209829-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209829-002AB1a50c72e98297…

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 Pharmaceuticals USA Inc.21a89264-8047-40ac-8b10-fa64610725092026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209829
application number: ANDA209829
tofacitinibTOFACITINIBZydus Lifesciences Limitedf4d0e580-74a8-496e-89a2-d74478c946bf2026-05-29Exact identifier
application applno (ANDA): 209829
application number: ANDA209829

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58814ORIG2019-05-21