FDA.reportPublic FDA data

Application 203855

Type
ANDA
Sponsor
SCIEGEN PHARMS 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;ORAL0.75MGNoNo
005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL1MGNoNo
006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDETABLET;ORAL1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-906PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-907PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-908PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-909PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-910PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-911PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.ANDACurrent
42543-704Pramipexole DihydrochloridePramipexole DihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-705Pramipexole DihydrochloridePramipexole DihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-706Pramipexole DihydrochloridePramipexole DihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-707Pramipexole DihydrochloridePramipexole DihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-708Pramipexole DihydrochloridePramipexole DihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-709Pramipexole DihydrochloridePramipexole DihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
50090-3009PRAMIPEXOLEPRAMIPEXOLEA-S Medication SolutionsANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-126Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-127Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-128Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-129Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-130Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
50228-131Pramipexole DihydrochloridePramipexole DihydrochlorideScieGen Pharmaceuticals IncANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, IncANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent
60429-085Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, IncANDACurrent
60429-086Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, IncANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-087Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-089Pramipexole DihydrochloridePramipexole DihydrochlorideGolden State Medical SupplyANDACurrent