FDA.reportPublic FDA data

Application 022231

Type
NDA
Sponsor
MALLINCKRODT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERLIVAZTERLIPRESSININJECTABLE;INJECTION0.85MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43825-200TerlivazTerlipressinMallinckrodt Hospital Products Inc.NDACurrent
43825-200TerlivazTerlipressinMallinckrodt Hospital Products Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73127SUPPL2023-01-10
73125SUPPL2023-01-10
72261ORIG2022-10-07
72086ORIG2022-09-15
72077ORIG2022-09-14