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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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-d326-5099-911bfe33e3912026-08-14Adverse reactionsName fallback
brand name: JASCAYD
generic name: NERANDOMILAST

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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