FDA.reportPublic FDA data

Application 212378

Type
ANDA
Sponsor
INNOGENIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL10MGNoNo
002BACLOFENBACLOFENTABLET;ORAL20MGNoNo
003BACLOFENBACLOFENTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-138BaclofenBaclofenCamber Pharmaceuticals, Inc.ANDACurrent
31722-998BaclofenBaclofenCamber Pharmaceuticals, Inc.ANDACurrent
31722-998BaclofenBaclofenCamber Pharmaceuticals, Inc.ANDACurrent
31722-999BaclofenBaclofenCamber Pharmaceuticals, Inc.ANDACurrent
31722-999BaclofenBaclofenCamber Pharmaceuticals, Inc.ANDACurrent
50090-5838BaclofenBaclofenA-S Medication SolutionsANDACurrent
50090-5855BaclofenBaclofenA-S Medication SolutionsANDACurrent
63629-1224BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1224BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1224BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1225BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1225BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1225BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1226BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1226BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1226BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1227BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1227BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1227BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1228BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1228BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-1228BaclofenBaclofenBryant Ranch PrepackANDACurrent
68071-2414BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2414BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2420BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7915BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7915BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8181BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3089BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-3089BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-3115BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-3115BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
71335-1796BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1797BaclofenBaclofenBryant Ranch PrepackANDACurrent
71610-660BaclofenBaclofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0156BaclofenBaclofen 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0156BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0156BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0156BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0205BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent