FDA.reportPublic FDA data

Application 217642

Type
ANDA
Sponsor
TEVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ELAGOLIXELAGOLIXTABLET; FILM COATED200MGNoNo

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
OrilissaELAGOLIXAbbVie Inc.a86757b3-09c5-fd3b-1223-244e94f50a662025-12-19Warnings, Adverse reactionsName fallback
generic name: ELAGOLIX

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81315ORIG 2025-02-24