Application 207923

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEEBRIGLYCOPYRROLATEPOWDER;INHALATION15.6MCG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0662SEEBRI NEOHALERglycopyrrolateNovartis Pharmaceuticals CorporationNDACurrent
63402-815SEEBRI NEOHALERGLYCOPYRROLATESunovion Pharmacueticals Inc.NDACurrent
63402-815SEEBRI NEOHALERGLYCOPYRROLATESunovion Pharmacueticals Inc.NDACurrent
63402-815SEEBRI NEOHALERGLYCOPYRROLATESunovion Pharmacueticals Inc.NDACurrent
63402-815SEEBRI NEOHALERGLYCOPYRROLATESunovion Pharmacueticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68251SUPPL2021-08-02
68244SUPPL2021-08-02
46945SUPPL2017-01-24
46942SUPPL2017-01-24
46078ORIG2016-12-06
46028ORIG2016-12-06
32864ORIG2015-11-03
19972ORIG2015-11-03