FDA.reportPublic FDA data

Application 079165

Type
ANDA
Sponsor
MLV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.25MG BASENoNo
002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.5MG BASENoNo
003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo
004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 3MG BASENoNo
006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-673RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-673RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-673RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-673RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-673RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-674RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-674RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-674RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-674RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-674RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-675RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-675RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-675RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-675RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-675RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-676RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-676RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-676RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-676RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-676RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-677RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-677RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-677RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-677RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-677RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-678RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-678RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-678RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-678RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-678RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-679RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-679RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-679RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-679RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
10135-679RopiniroleropiniroleMarlex Pharmaceuticals IncANDACurrent
60505-2865RopiniroleRopiniroleApotex Corp.ANDACurrent
60505-2866RopiniroleRopiniroleApotex Corp.ANDACurrent
60505-2867RopiniroleRopiniroleApotex Corp.ANDACurrent
60505-2868RopiniroleRopiniroleApotex Corp.ANDACurrent
60505-2869RopiniroleRopiniroleApotex Corp.ANDACurrent
60505-2870RopiniroleRopiniroleApotex Corp.ANDACurrent
60505-2871RopiniroleRopiniroleApotex Corp.ANDACurrent