FDA.reportPublic FDA data

Application 074069

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7568AzathioprineAzathioprineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-071AZATHIOPRINEAzathioprineAvKAREANDACurrent
42291-071AZATHIOPRINEAzathioprineAvKAREANDACurrent
60219-1076AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1076AZATHIOPRINEAzathioprineAmneal Pharmaceuticals LLCANDACurrent
60219-1076AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1076AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1076AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-2036AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-2036AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-2037AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
60219-2037AZATHIOPRINEAzathioprineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1076AZATHIOPRINEAzathioprineAmneal Pharmaceuticals of New York, LLCANDACurrent
71610-124AZATHIOPRINEAzathioprineAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-129AZATHIOPRINEAzathioprinePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-129AZATHIOPRINEAzathioprinePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-129AZATHIOPRINEAzathioprinePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-129AZATHIOPRINEAzathioprinePD-Rx Pharmaceuticals, Inc.ANDACurrent