FDA.reportPublic FDA data

Application 217933

Type
NDA
Sponsor
BTG INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AURLUMYNILOPROSTSOLUTION;INTRAVENOUS100MCG/ML (100MCG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80910ORIG 2025-02-04
78508SUPPL 2024-05-20
78484SUPPL 2024-05-15
77503ORIG 2024-02-15
77496ORIG 2024-02-14