FDA.reportPublic FDA data

Application 210850

Type
NDA
Sponsor
MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SINCALIDESINCALIDEINJECTABLE;INJECTION5MCG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70511-131SincalideSincalideMAIA Pharmaceuticals, Inc.NDACurrent
72266-248SincalideSincalideFOSUN PHARMA USA INCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76384ORIG 2023-11-06
75875SUPPL 2023-10-20
75834SUPPL 2023-10-18
72713ORIG2022-11-25
72684ORIG2022-11-23
52719ORIG2018-02-26