FDA.reportPublic FDA data

Application 077604

Type
ANDA
Sponsor
YABAO PHARM

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
0904-7104GalantaminegalantamineMajor PharmaceuticalsANDACurrent
70436-004GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-004GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-004GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-004GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-004GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-005GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-005GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-005GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-005GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-005GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-006GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-006GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-006GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-006GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent
70436-006GalantaminegalantamineSlate Run Pharmaceuticals, LLCANDACurrent