FDA.reportPublic FDA data

Application 208437

Type
NDA
Sponsor
SUNOVION RESP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LONHALA MAGNAIR KITGLYCOPYRROLATESOLUTION;INHALATION25MCG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
63402-201LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-201LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-201LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-301LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-301LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-301LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59179SUPPL2019-06-27
59167SUPPL2019-06-25
56560ORIG2018-11-26
56096ORIG2018-10-26
50621ORIG2017-12-06