FDA.reportPublic FDA data

Application 209184

Type
NDA
Sponsor
ACORDA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INBRIJALEVODOPAPOWDER;INHALATION42MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10144-342InbrijalevodopaAcorda Therapeutics, Inc.NDACurrent
10144-342InbrijalevodopaAcorda Therapeutics, Inc.NDACurrent
10144-342InbrijalevodopaAcorda Therapeutics, Inc.NDACurrent
10144-342InbrijalevodopaAcorda Therapeutics, Inc.NDACurrent
10144-342InbrijalevodopaAcorda Therapeutics, Inc.NDACurrent
10144-342InbrijalevodopaAcorda Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85620SUPPL 2026-04-02
85619SUPPL 2026-04-02
64501SUPPL2020-09-04
64500SUPPL2020-09-04
64479SUPPL2020-09-02
64478SUPPL2020-09-02
59889SUPPL2019-08-30
58866ORIG2019-05-28
57064ORIG2018-12-30
57033ORIG2018-12-26