Application 218230

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLUJEPAGEPOTIDACIN MESYLATETABLET;ORALEQ 750MG BASEYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84969SUPPL 2026-02-09
84398SUPPL 2025-12-12
84388SUPPL 2025-12-11
81946ORIG 2025-04-21
81744ORIG 2025-03-27
81707ORIG 2025-03-25