FDA.reportPublic FDA data

Application 077852

Type
ANDA
Sponsor
HIKMA

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
0054-0116RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0116RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0117RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0117RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0118RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0118RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0119RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0119RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0120RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0120RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0121RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0121RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0122RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0122RopinirolerOPINIRoleWest-Ward Pharmaceuticals Corp.ANDACurrent
43353-911RopinirolerOPINIRoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-912RopinirolerOPINIRoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-920RopinirolerOPINIRoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2850RopinirolerOPINIRoleA-S Medication SolutionsANDACurrent
63629-6452RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-6452RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7137RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7137RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7137RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7137RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7139RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7139RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7139RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
63629-7139RopinirolerOPINIRoleBryant Ranch PrepackANDACurrent
68151-4071RopinirolerOPINIRoleCarilion Materials ManagementANDACurrent
68151-4072RopinirolerOPINIRoleCarilion Materials ManagementANDACurrent
68151-4073RopinirolerOPINIRoleCarilion Materials ManagementANDACurrent