FDA.reportPublic FDA data

Application 090178

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALEQ 8MG BASENoNo
002GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALEQ 16MG BASENoNo
003GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDECAPSULE, EXTENDED RELEASE;ORALEQ 24MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-835Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-835Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-835Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-835Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-836Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-836Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-836Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-836Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-837Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-837Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-837Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-837Galantamine HydrobromideGalantamine HydrobromideSun Pharmaceutical Industries, Inc.ANDACurrent
63629-2363Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2363Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2363Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2364Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2364Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2364Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2365Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2365Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent
63629-2365Galantamine HydrobromideGalantamine HydrobromideBryant Ranch PrepackANDACurrent