FDA.reportPublic FDA data

Application 211765

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UBRELVYUBROGEPANTTABLET;ORAL50MGYesNo
002UBRELVYUBROGEPANTTABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82554SUPPL 2025-06-13
82477SUPPL 2025-06-06
81712SUPPL 2025-03-25
81699SUPPL 2025-03-24
73578SUPPL 2023-02-21
73555SUPPL 2023-02-17
66481SUPPL2021-03-04
61608ORIG2020-01-22
61456ORIG2019-12-26
61434ORIG2019-12-23