FDA.reportPublic FDA data

Application 210450

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORILISSAELAGOLIX SODIUMTABLET;ORALEQ 150MG BASEYesNo
002ORILISSAELAGOLIX SODIUMTABLET;ORALEQ 200MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-0038OrilissaElagolixAbbVie Inc.NDACurrent
0074-0038OrilissaElagolixAbbVie Inc.NDACurrent
0074-0038OrilissaElagolixAbbVie Inc.NDACurrent
0074-0038OrilissaElagolixAbbVie Inc.NDACurrent
0074-0038OrilissaElagolixAbbVie Inc.NDACurrent
0074-0038OrilissaElagolixAbbVie Inc.NDACurrent
0074-0039OrilissaElagolixAbbVie Inc.NDACurrent
0074-0039OrilissaElagolixAbbVie Inc.NDACurrent
0074-0039OrilissaElagolixAbbVie Inc.NDACurrent
0074-0039OrilissaElagolixAbbVie Inc.NDACurrent
0074-0039OrilissaElagolixAbbVie Inc.NDACurrent
0074-0039OrilissaElagolixAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84467SUPPL 2025-12-19
74447SUPPL 2023-06-06
74438SUPPL 2023-06-06
74437SUPPL 2023-06-05
66105SUPPL2021-02-05
66104SUPPL2021-02-05
66103SUPPL2021-02-05
66102SUPPL2021-02-05
66101SUPPL2021-02-05
66100SUPPL2021-02-05
66079SUPPL2021-02-03
66078SUPPL2021-02-03
66077SUPPL2021-02-03
59891SUPPL2019-08-30
59878SUPPL2019-08-29
59877SUPPL2019-08-29
55267ORIG2018-08-22
54957ORIG2018-07-24
54956ORIG2018-07-24