FDA.reportPublic FDA data

Application 077590

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 4MG BASENoNo
002GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 8MG BASENoNo
003GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 12MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2721GalantaminegalantamineMylan Pharmaceuticals Inc.ANDACurrent
0378-2721GalantaminegalantamineMylan Pharmaceuticals IncANDACurrent
0378-2722GalantaminegalantamineMylan Pharmaceuticals Inc.ANDACurrent
0378-2722GalantaminegalantamineMylan Pharmaceuticals IncANDACurrent
0378-2723GalantaminegalantamineMylan Pharmaceuticals Inc.ANDACurrent
0378-2723GalantaminegalantamineMylan Pharmaceuticals IncANDACurrent
0615-7541GalantamineGalantamineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7542GalantamineGalantamineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7543GalantamineGalantamineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-852GalantaminegalantamineMylan Institutional Inc.ANDACurrent
51079-853GalantaminegalantamineMylan Institutional Inc.ANDACurrent