FDA.reportPublic FDA data

Application 078920

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL0.125MGNoNo
002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL0.25MGNoNo
003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL0.5MGNoNo
004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL1MGNoNo
005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL1.5MGNoNo
006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL0.75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1388Pramipexole DihydrochloridePramipexole DihydrochlorideA-S Medication SolutionsANDACurrent
50090-1451Pramipexole DihydrochloridePramipexole DihydrochlorideA-S Medication SolutionsANDACurrent
63629-5034Pramipexole DihydrochloridePramipexole DihydrochlorideBryant Ranch PrepackANDACurrent
63629-5034PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch PrepackANDACurrent
65841-734PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-734PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-734PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-734PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-734PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-735PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-735PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-735PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-735PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-735PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-736PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-736PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-736PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-736PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-736PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-737PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-737PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-737PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-737PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-737PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-738PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-738PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-738PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-738PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-738PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-844PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
68084-440Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-440Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-793Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-793Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-974Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-974Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-982Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68084-982Pramipexole DihydrochloridePramipexole DihydrochlorideAmerican Health PackagingANDACurrent
68382-196Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-196Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-196Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-196Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-196Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-196Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-197Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-197Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-197Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-197Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-197Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-197Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-198Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-198Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-198Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-198Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-198Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-198Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-199Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-199Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-199Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-199Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-199Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-199Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-200Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-200Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-200Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-200Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-200Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-200Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-440Pramipexole DihydrochloridePramipexole DihydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent