FDA.reportPublic FDA data

Application 207930

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UTIBRONGLYCOPYRROLATE; INDACATEROL MALEATEPOWDER;INHALATION15.6MCG/INH;27.5MCG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0664UTIBRON NEOHALERindacaterol and glycopyrrolateNovartis Pharmaceuticals CorporationNDACurrent
63402-681UTIBRON NEOHALERINDACATEROL MALEATE and GLYCOPYRROLATESunovion Pharmaceuticals Inc.NDACurrent
63402-681UTIBRON NEOHALERINDACATEROL MALEATE and GLYCOPYRROLATESunovion Pharmaceuticals Inc.NDACurrent
63402-681UTIBRON NEOHALERINDACATEROL MALEATE and GLYCOPYRROLATESunovion Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68259SUPPL2021-08-02
68258SUPPL2021-08-02
68253SUPPL2021-08-02
68252SUPPL2021-08-02
58940SUPPL2019-06-04
58900SUPPL2019-05-31
47007SUPPL2017-01-30
46972SUPPL2017-01-25
45969ORIG2016-11-29
40595ORIG2015-11-04
10628ORIG2015-11-03