FDA.reportPublic FDA data

Application 091019

Type
ANDA
Sponsor
NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHENODIOLCHENODIOLTABLET;ORAL250MGNoYes

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
A091019-001CHENODIOLCHENODIOL250MGTABLET / ORALRS2009-10-22

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 22:54:322026-06A091019-001CHENODIOL250MGTABLET / ORALRS2009-10-22a50c72e98297…

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
ChenodalCHENODIOLTravere Therapeutics769e0a3b-826d-4faf-9129-5eeb7ebe0b672025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091019
application number: ANDA091019
ndc (product): 68974-876

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0722-7121ChenodiolChenodiolNexgen Pharma, Inc.ANDACurrent
0722-7121ChenodiolChenodiolNexgen Pharma, Inc.ANDACurrent
45043-876ChenodalChenodiolManchester Pharmaceuticals Inc.ANDACurrent
68974-876ChenodalChenodiolRetrophin, Inc.ANDACurrent
68974-876ChenodalChenodiolRetrophin, Inc.ANDACurrent
68974-876ChenodalChenodiolRetrophin, Inc.ANDACurrent
68974-876ChenodalChenodiolRetrophin, Inc.ANDACurrent
68974-876ChenodalChenodiolRetrophin, Inc.ANDACurrent
68974-876ChenodalChenodiolTravere TherapeuticsANDACurrent
79739-7121ChenodiolChenodiolLGM Pharma Solutions, LLCANDACurrent