FDA.reportPublic FDA data

Application 207863

Type
ANDA
Sponsor
ATHEM

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
14803-502Labetalol HydrochlorideLabetalol HydrochlorideELYSIUM PHARMACEUTICALS LIMITEDANDACurrent
14803-503Labetalol HydrochlorideLabetalol HydrochlorideELYSIUM PHARMACEUTICALS LIMITEDANDACurrent
14803-504Labetalol HydrochlorideLabetalol HydrochlorideELYSIUM PHARMACEUTICALS LIMITEDANDACurrent
50090-4917Labetalol HydrochlorideLabetalol HydrochlorideA-S Medication SolutionsANDACurrent
50090-4917Labetalol HydrochlorideLabetalol HydrochlorideA-S Medication SolutionsANDACurrent
63629-2053Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-2053Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-2054Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-2054Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-2055Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-2055Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
70518-2728Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2728Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2728Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2903Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2903Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-574Labetalol HydrochlorideLabetalol HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-751Labetalol HydrochlorideLabetalol HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71930-035Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-035Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-035Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-036Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-036Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-036Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-037Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-037Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent
71930-037Labetalol HydrochlorideLabetalol HydrochlorideEywa Pharma IncANDACurrent