FDA.reportPublic FDA data

Application 202129

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZETONNACICLESONIDEAEROSOL, METERED;NASAL0.037MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63402-737ZetonnaciclesonideSunovion Pharmaceuticals NDACurrent
63402-737ZetonnaciclesonideSunovion Pharmaceuticals Inc.NDACurrent
66993-015CiclesonideciclesonidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70515-737ZetonnaciclesonideCovis Pharma US, IncNDACurrent
70515-737ZetonnaciclesonideCovis PharmaNDACurrent
70515-737ZetonnaciclesonideCovis Pharma US, IncNDACurrent
70515-737ZetonnaciclesonideCovis PharmaNDACurrent
70515-737ZetonnaciclesonideCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73552SUPPL 2023-02-17
73547SUPPL 2023-02-17
40128SUPPL2014-11-18
40127SUPPL2014-11-18
19069SUPPL2014-11-18
32189SUPPL2014-10-27
9971SUPPL2014-10-27
9970SUPPL2014-10-27
44846ORIG2012-11-05
22872ORIG2012-11-05
32188ORIG2012-01-25
40126ORIG2012-01-24
53036SUPPL1900-01-01
53035SUPPL1900-01-01
52421SUPPL1900-01-01