FDA.reportPublic FDA data

Application 077621

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZATHIOPRINEAZATHIOPRINETABLET;ORAL50MGNoNo
002AZATHIOPRINEAZATHIOPRINETABLET;ORAL25MGNoNo
003AZATHIOPRINEAZATHIOPRINETABLET;ORAL75MGNoNo
004AZATHIOPRINEAZATHIOPRINETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-484AzathioprineAzathioprineRebel Distributors Corp..ANDACurrent
33261-758AzathioprineAzathioprineAidarex Pharmaceuticals LLCANDACurrent
65841-602AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
65841-602AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
65841-602AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
65841-602AzathioprineAzathioprineZydus Lifesciences LimitedANDACurrent
68084-229AzathioprineAzathioprineAmerican Health PackagingANDACurrent
68084-229AzathioprineAzathioprineAmerican Health PackagingANDACurrent
68084-229AzathioprineAzathioprineAmerican Health PackagingANDACurrent
68382-003AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-003AzathioprineAzathioprineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-003AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-118AzathioprineAzathioprineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-118AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-118AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-119AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-119AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-119AzathioprineAzathioprineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-120AzathioprineAzathioprineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-120AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-120AzathioprineAzathioprineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1139AzathioprineAzathioprineZydus Lifesciences LimitedANDACurrent
70771-1139AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1139AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1139AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1140AzathioprineAzathioprineZydus Lifesciences LimitedANDACurrent
70771-1140AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1140AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1140AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1141AzathioprineAzathioprineZydus Lifesciences LimitedANDACurrent
70771-1141AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1141AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent
70771-1141AzathioprineAzathioprineCadila Healthcare LimitedANDACurrent