FDA.reportPublic FDA data

Application 090403

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE;ORAL25MGNoNo
002INDOMETHACININDOMETHACINCAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42708-030indomethacinindomethacinQPharma IncANDACurrent
42708-030indomethacinindomethacinQPharma IncANDACurrent
50090-2821indomethacinindomethacinA-S Medication SolutionsANDACurrent
50090-3014indomethacinindomethacinA-S Medication SolutionsANDACurrent
50090-3022indomethacinindomethacinA-S Medication SolutionsANDACurrent
50090-3097indomethacinindomethacinA-S Medication SolutionsANDACurrent
63187-852indomethacinindomethacinProficient Rx LPANDACurrent
63187-852indomethacinindomethacinProficient Rx LPANDACurrent
67296-1512indomethacinindomethacinRedPharm Drug, Inc.ANDACurrent
67296-1512indomethacinindomethacinRedPharm Drug, Inc.ANDACurrent
68071-4091indomethacinindomethacinNuCare Pharmaceuticals,Inc.ANDACurrent
68382-293indomethacinindomethacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-293indomethacinindomethacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-293indomethacinindomethacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-294indomethacinindomethacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-294indomethacinindomethacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-294indomethacinindomethacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1004indomethacinindomethacinCadila Healthcare LimitedANDACurrent
70771-1004indomethacinindomethacinCadila Healthcare LimitedANDACurrent
70771-1004indomethacinindomethacinCadila Healthcare LimitedANDACurrent
70771-1004indomethacinindomethacinZydus Lifesciences LimitedANDACurrent
70771-1005indomethacinindomethacinCadila Healthcare LimitedANDACurrent
70771-1005indomethacinindomethacinZydus Lifesciences LimitedANDACurrent
70771-1005indomethacinindomethacinCadila Healthcare LimitedANDACurrent
70771-1005indomethacinindomethacinCadila Healthcare LimitedANDACurrent
72578-038IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-038IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-038IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-038IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-038IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-039IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-039IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-039IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-039IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent
72578-039IndomethacinIndomethacinViona Pharmaceuticals IncANDACurrent