FDA.reportPublic FDA data

Application 210595

Type
NDA
Sponsor
CIRCASSIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUAKLIR PRESSAIRACLIDINIUM BROMIDE; FORMOTEROL FUMARATEPOWDER, METERED;INHALATION0.4MG/INH;0.012MG/INHNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0900DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarateAstraZeneca Pharmaceuticals LPNDACurrent
72124-001DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarteCircassia Pharmaceuticals Inc.NDACurrent
72124-001DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarteCircassia Pharmaceuticals Inc.NDACurrent
72124-001DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarteCircassia Pharmaceuticals Inc.NDACurrent
72124-001DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarteCircassia Pharmaceuticals Inc.NDACurrent
72124-001DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarteCircassia Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60579ORIG2019-10-17
58160ORIG2019-04-01
58141ORIG2019-03-29