FDA.reportPublic FDA data

Application 207743

Type
ANDA
Sponsor
ZYDUS PHARMS

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
0904-7109Labetalol HydrochlorideLabetalol HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7110Labetalol HydrochlorideLabetalol HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7111Labetalol HydrochlorideLabetalol HydrochlorideMajor PharmaceuticalsANDACurrent
55154-2339Labetalol HydrochlorideLabetalol HydrochlorideCardinal HealthANDACurrent
55154-2339Labetalol HydrochlorideLabetalol HydrochlorideCardinal HealthANDACurrent
55154-8192Labetalol HydrochlorideLabetalol HydrochlorideCardinal Health 107, LLCANDACurrent
55154-8192Labetalol HydrochlorideLabetalol HydrochlorideCardinal HealthANDACurrent
60687-439Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-439Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-439Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-450Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-450Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-450Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-461Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-461Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
60687-461Labetalol HydrochlorideLabetalol HydrochlorideAmerican Health PackagingANDACurrent
68001-381Labetalol HydrochlorideLabetalol HydrochlorideBluePoint Laboratories Inc.ANDACurrent
68001-381Labetalol HydrochlorideLabetalol HydrochlorideBluePoint Laboratories Inc.ANDACurrent
68001-382Labetalol HydrochlorideLabetalol HydrochlorideBluePoint Laboratories Inc.ANDACurrent
68001-382Labetalol HydrochlorideLabetalol HydrochlorideBluePoint Laboratories Inc.ANDACurrent
68001-383Labetalol HydrochlorideLabetalol HydrochlorideBluePoint Laboratories Inc.ANDACurrent
68001-383Labetalol HydrochlorideLabetalol HydrochlorideBluePoint Laboratories Inc.ANDACurrent
68382-798Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-798Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-798Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-798Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-799Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-799Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-799Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-799Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-800Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-800Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-800Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-800Labetalol HydrochlorideLabetalol HydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70518-1132Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1132Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1132Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1132Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1132Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1163Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1163Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1163Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1163Labetalol HydrochlorideLabetalol HydrochlorideREMEDYREPACK INC.ANDACurrent
70771-1163Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1163Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1163Labetalol HydrochlorideLabetalol HydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1163Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1164Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1164Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1164Labetalol HydrochlorideLabetalol HydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1164Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1165Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1165Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1165Labetalol HydrochlorideLabetalol HydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1165Labetalol HydrochlorideLabetalol HydrochlorideCadila Healthcare LimitedANDACurrent
71335-1242Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1242Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent