FDA.reportPublic FDA data

Application 215562

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL2.5MG;6.25MGNoNo
002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MGNoNo
003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;6.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-740Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideMarlex Pharmaceuticals, Inc.ANDACurrent
10135-741Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideMarlex Pharmaceuticals, Inc.ANDACurrent
10135-742Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideMarlex Pharmaceuticals, Inc.ANDACurrent
70954-412Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideNovitium Pharma LLCANDACurrent
70954-412Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideNovitium Pharma LLCANDACurrent
70954-413Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideNovitium Pharma LLCANDACurrent
70954-413Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideNovitium Pharma LLCANDACurrent
70954-414Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideNovitium Pharma LLCANDACurrent
70954-414Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideNovitium Pharma LLCANDACurrent