FDA.reportPublic FDA data

Application 078962

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo
002BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-013BETAXOLOL HYDROCHLORIDEbetaxolol hydrochlorideKVK-TECH, INC.ANDACurrent
10702-013BETAXOLOL HYDROCHLORIDEbetaxolol hydrochlorideKVK-TECH, INC.ANDACurrent
10702-014BETAXOLOL HYDROCHLORIDEbetaxolol hydrochlorideKVK-TECH, INC.ANDACurrent
10702-014BETAXOLOL HYDROCHLORIDEbetaxolol hydrochlorideKVK-TECH, INC.ANDACurrent
60429-753BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-753BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-753BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-753BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-753BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-754BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-754BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent
60429-754BetaxololBetaxololGolden State Medical Supply, Inc.ANDACurrent