FDA.reportPublic FDA data

Application 210922

Type
NDA
Sponsor
ALNYLAM PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONPATTROPATISIRAN SODIUMSOLUTION;INTRAVENOUSEQ 10MG BASE/5ML (EQ 2MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent
71336-1000OnpattropatisiranAlnylam Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73195SUPPL2023-01-17
73185SUPPL2023-01-17
72267SUPPL2022-10-07
72239SUPPL2022-10-04
67474SUPPL2021-05-12
67445SUPPL2021-05-10
62610SUPPL2020-04-20
62599SUPPL2020-04-20
60029SUPPL2019-09-18
60021SUPPL2019-09-17
58662SUPPL2019-05-13
58602SUPPL2019-05-07
55395ORIG2018-09-07
55169ORIG2018-08-13
55153ORIG2018-08-10