FDA.reportPublic FDA data

Application 210923

Type
NDA
Sponsor
SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MULPLETALUSUTROMBOPAGTABLET;ORAL3MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59630-551MulpletaLusutrombopagSHIONOGI INC.NDACurrent
59630-551MulpletaLusutrombopagSHIONOGI INC.NDACurrent
59630-551MulpletaLusutrombopagSHIONOGI INC.NDACurrent
59630-551MulpletaLusutrombopagSHIONOGI INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55265ORIG2018-08-22
55077ORIG2018-08-02
55062ORIG2018-07-31