FDA.reportPublic FDA data

Application 211953

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL100MGNoNo
002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL200MGNoNo
003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60760-784LABETALOL HYDROCHLORIDELabetalol HydrochlorideST. MARY'S MEDICAL PARK PHARMACYANDACurrent
70518-3499LABETALOL HYDROCHLORIDELabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3499LABETALOL HYDROCHLORIDELabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3557LABETALOL HYDROCHLORIDELabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-2169LABETALOL HYDROCHLORIDELabetalol HydrochlorideBryant Ranch PrepackANDACurrent
72888-120LABETALOL HYDROCHLORIDELabetalol HydrochlorideAdvagen Pharma LtdANDACurrent
72888-121LABETALOL HYDROCHLORIDELabetalol HydrochlorideAdvagen Pharma LtdANDACurrent
72888-122LABETALOL HYDROCHLORIDELabetalol HydrochlorideAdvagen Pharma LtdANDACurrent