Application 216921

Type
ANDA
Sponsor
NATCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IDELALISIBIDELALISIBTABLET;ORAL100MGNoNo
002IDELALISIBIDELALISIBTABLET;ORAL150MGNoNo

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
A216921-001IDELALISIBIDELALISIB100MGTABLET / ORALAB2026-02-17
A216921-002IDELALISIBIDELALISIB150MGTABLET / ORALAB2026-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216921-001AB
A216921-002AB

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 22:54:322026-06A216921-001IDELALISIB100MGTABLET / ORALAB2026-02-17a50c72e98297…
2026-08-01 22:54:322026-06A216921-002IDELALISIB150MGTABLET / ORALAB2026-02-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216921-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216921-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZydeligIDELALISIBGilead Sciences, Inc.efbdafa9-d18c-4e85-b4a2-1e620fc74e502025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IDELALISIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85402ORIG 2026-03-19