FDA.reportPublic FDA data

Application 216775

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACALABRUTINIBACALABRUTINIBCAPSULE;ORAL100MGNoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALQUENCEACALABRUTINIBAstraZeneca Pharmaceuticals LPb1409184-3267-4d8c-8f17-4e01f69828b12026-02-19Warnings, Adverse reactionsName fallback
generic name: ACALABRUTINIB
CALQUENCEACALABRUTINIBAstraZeneca Pharmaceuticals LPdd4835ef-e1bc-4997-a399-1ffa2556fbfe2026-02-19Warnings, Adverse reactionsName fallback
generic name: ACALABRUTINIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73416ORIG 2023-02-08