FDA.reportPublic FDA data

Application 021658

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ALVESCOCICLESONIDEAEROSOL, METERED;INHALATION0.08MG/INHYesYes
003ALVESCOCICLESONIDEAEROSOL, METERED;INHALATION0.16MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63402-711AlvescociclesonideSunovion Pharmaceuticals Inc.NDACurrent
63402-711AlvescociclesonideSunovion Pharmaceuticals NDACurrent
63402-712AlvescociclesonideSunovion Pharmaceuticals NDACurrent
63402-712AlvescociclesonideSunovion Pharmaceuticals Inc.NDACurrent
66993-571CiclesonideciclesonidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-572CiclesonideciclesonidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70515-711AlvescociclesonideCovis PharmaNDACurrent
70515-711AlvescociclesonideCovis PharmaNDACurrent
70515-711AlvescociclesonideCovis PharmaNDACurrent
70515-711AlvescociclesonideCovis Pharma US, IncNDACurrent
70515-711AlvescociclesonideCovis Pharma US, IncNDACurrent
70515-711AlvescociclesonideCovis PharmaNDACurrent
70515-712AlvescociclesonideCovis PharmaNDACurrent
70515-712AlvescociclesonideCovis Pharma US, IncNDACurrent
70515-712AlvescociclesonideCovis Pharma US, IncNDACurrent
70515-712AlvescociclesonideCovis PharmaNDACurrent
70515-712AlvescociclesonideCovis PharmaNDACurrent
70515-712AlvescociclesonideCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73551SUPPL 2023-02-17
73546SUPPL 2023-02-17
5934SUPPL2012-12-21
37411SUPPL2012-12-17
15934SUPPL2012-11-26
28323SUPPL2012-11-21
42256ORIG2009-07-20
24208ORIG2009-07-20
37410SUPPL2009-01-02
5933SUPPL2008-12-29
37409ORIG2008-01-18
5932ORIG2008-01-18
53206ORIG1900-01-01
53205ORIG1900-01-01
53204ORIG1900-01-01