FDA.reportPublic FDA data

Application 203659

Type
ANDA
Sponsor
AMERIGEN PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 2.5MG BASENoNo
002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-248NebivololNebivololAmerigen Pharmaceuticals Inc.ANDACurrent
43975-249NebivololNebivololAmerigen Pharmaceuticals Inc.ANDACurrent
43975-250NebivololNebivololAmerigen Pharmaceuticals Inc.ANDACurrent
43975-251NebivololNebivololAmerigen Pharmaceuticals Inc.ANDACurrent
51407-483NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-483NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-483NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-483NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-483NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-484NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-484NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-484NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-484NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-484NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-485NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-485NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-485NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-485NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-485NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-486NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-486NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-486NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
51407-486NebivololNebivololGolden State Medical Supply, Inc.ANDACurrent
62559-275NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-275NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-275NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-276NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-276NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-276NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-277NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-277NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-277NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-278NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-278NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent
62559-278NebivololNebivololANI Pharmaceuticals, Inc.ANDACurrent