FDA.reportPublic FDA data

Application 078110

Type
ANDA
Sponsor
PRINSTON INC

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
43353-194ropinirole hydrochlorideropinirole hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-195ropinirole hydrochlorideropinirole hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-196ropinirole hydrochlorideropinirole hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-198ropinirole hydrochlorideropinirole hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43547-268ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-268ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-268ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-268ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-269ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-269ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-269ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-269ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-270ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-270ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-270ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-270ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-271ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-271ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-271ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-271ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-272ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-272ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-272ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-272ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-273ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-273ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-273ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-273ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-274ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-274ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-274ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-274ropinirole hydrochlorideropinirole hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-595ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-595ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-596ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-596ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-597ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-597ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-598ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-598ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-599ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-599ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-600ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-600ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-601ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
43547-601ropinirole hydrochlorideropinirole hydrochlorideSOLCO HEALTHCARE US, LLCANDACurrent
50090-1330ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-1330ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-4348ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-4348ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-4348ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-4348ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-4810ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50090-4810ropinirole hydrochlorideropinirole hydrochlorideA-S Medication SolutionsANDACurrent
50268-741ropinirole hydrochlorideropinirole hydrochlorideAvPAKANDACurrent
50268-742ropinirole hydrochlorideropinirole hydrochlorideAvPAKANDACurrent
50268-743ropinirole hydrochlorideropinirole hydrochlorideAvPAKANDACurrent
50268-744ropinirole hydrochlorideropinirole hydrochlorideAvPAKANDACurrent
51655-360ropinirole hydrochlorideropinirole hydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-360ropinirole hydrochlorideropinirole hydrochlorideNorthwind PharmaceuticalsANDACurrent
55700-252ropinirole hydrochlorideropinirole hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-673ropinirole hydrochlorideropinirole hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-685ropinirole hydrochlorideropinirole hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-685ropinirole hydrochlorideropinirole hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-577Ropinirole HydrochlorideRopinirole HydrochlorideAmerican Health PackagingANDACurrent
60687-577Ropinirole HydrochlorideRopinirole HydrochlorideAmerican Health PackagingANDACurrent
60687-588Ropinirole HydrochlorideRopinirole HydrochlorideAmerican Health PackagingANDACurrent
60687-588Ropinirole HydrochlorideRopinirole HydrochlorideAmerican Health PackagingANDACurrent
63629-4641ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
63629-4798ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
63629-4798ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
63629-4798ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
63629-7023ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
63629-7152ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
63629-7152ropinirole hydrochlorideropinirole hydrochlorideBryant Ranch PrepackANDACurrent
64220-420Ropinirole HydrochlorideRopinirole HydrochlorideZhejiang Huahai Pharmaceutical Co., Ltd.ANDACurrent
64220-421Ropinirole HydrochlorideRopinirole HydrochlorideZhejiang Huahai Pharmaceutical Co., Ltd.ANDACurrent
64220-422Ropinirole HydrochlorideRopinirole HydrochlorideZhejiang Huahai Pharmaceutical Co., Ltd.ANDACurrent
64220-423Ropinirole HydrochlorideRopinirole HydrochlorideZhejiang Huahai Pharmaceutical Co., Ltd.ANDACurrent
64220-424Ropinirole HydrochlorideRopinirole HydrochlorideZhejiang Huahai Pharmaceutical Co., Ltd.ANDACurrent