Application 018513

Type
NDA
Sponsor
LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CHENIXCHENODIOLTABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018513-002CHENIXCHENODIOL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1983-07-28

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2026-08-01 22:54:322026-06N018513-002CHENIX250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1983-07-28a50c72e98297…

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
CTEXLICHENODIOLMirum Pharmaceuticals Inc.015384e7-4ac5-4782-a309-e40cd1421c5b2025-12-16Warnings, Adverse reactionsName fallback
generic name: CHENODIOL
ChenodalCHENODIOLTravere Therapeutics769e0a3b-826d-4faf-9129-5eeb7ebe0b672025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHENODIOL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
938SUPPL2010-05-24