Application 220449

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JASCAYDNERANDOMILASTTABLET;ORAL9MGYesNo
002JASCAYDNERANDOMILASTTABLET;ORAL18MGYesYes

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JASCAYDNERANDOMILASTBoehringer Ingelheim Pharmaceuticals, Inc.fa1b14c6-957f-d326-5099-911bfe33e3912026-02-02Adverse reactionsName fallback
brand name: JASCAYD
generic name: NERANDOMILAST

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84517ORIG 2025-12-23
84516ORIG 2025-12-23
84474ORIG 2025-12-19