FDA.reportPublic FDA data

Application 211699

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEBUDESONIDE;FORMOTEROL FUMARATE DIHYDRATEUNKNOWNUNKNOWNNoNo
002BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEBUDESONIDE;FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATION0.16MG/INH; 0.0045MG/INHNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7502BREYNABudesonide and Formoterol FumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-7503BREYNABudesonide and Formoterol FumarateMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67037ORIG2021-04-13