Application 021430

Type
NDA
Sponsor
CELGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THALOMIDTHALIDOMIDECAPSULE; ORAL50MGNoNo
002THALOMIDTHALIDOMIDECAPSULE; ORAL100MGNoNo
003THALOMIDTHALIDOMIDECAPSULE; ORAL200MGNoNo

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
ThalomidTHALIDOMIDECelgene Corporation2eda833b-1357-4ed4-a093-194524fcb0612023-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thalomid
generic name: THALIDOMIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23999ORIG2012-03-09
42154ORIG2008-10-03
23660ORIG2006-06-06
36901ORIG2006-05-26
5351ORIG2006-05-26