FDA.reportPublic FDA data

Application 211215

Type
NDA
Sponsor
MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANGIOMAX RTUBIVALIRUDINSOLUTION;INTRAVENOUS250MG/50ML (5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70511-141bivalirudinbivalirudinMAIA Pharmaceuticals, Inc.NDACurrent
70511-141Angiomax RTUbivalirudinMAIA Pharmaceuticals, Inc.NDACurrent
70860-403BivalirudinbivalirudinAthenex Pharmaceutical Division, LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74209SUPPL 2023-05-10
74204SUPPL 2023-05-10
62107ORIG2020-03-10
59499ORIG2019-07-30
59473ORIG2019-07-26