FDA.reportPublic FDA data

Application 215239

Type
NDA
Sponsor
CATALYST PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AGAMREEVAMOROLONESUSPENSION;ORAL40MG/MLYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78731SUPPL 2024-07-02
78665SUPPL 2024-06-06
76515ORIG 2023-11-07
75965ORIG 2023-10-27
75950ORIG 2023-10-26