Application 079028

Type
ANDA
Sponsor
WATSON LABS

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
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3496GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3497GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
0591-3498GalantamineGalantamineActavis Pharma, Inc.ANDACurrent
43353-984Galantamine hydrobromideGalantamine hydrobromideAphena Pharma Solutions - Tennessee, LLCANDACurrent