FDA.reportPublic FDA data

Application 077751

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL10MGNoNo
002PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL20MGNoNo
003PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL40MGNoNo
004PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-867pravastatin sodiumpravastatin sodiumAidarex Pharmaceuticals LLCANDACurrent
33261-868pravastatin sodiumpravastatin sodiumAidarex Pharmaceuticals LLCANDACurrent
33261-953pravastatin sodiumpravastatin sodiumAidarex Pharmaceuticals LLCANDACurrent
43063-443pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-443pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-443pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-443pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-444pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-444pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-444pravastatin sodiumpravastatin sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1362pravastatin sodiumpravastatin sodiumA-S Medication SolutionsANDACurrent
50090-1434pravastatin sodiumpravastatin sodiumA-S Medication SolutionsANDACurrent
51655-071PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Pharmaceuticals, LLCANDACurrent
51655-072Pravastatin SodiumPravastatin SodiumNorthwind Pharmaceuticals, LLCANDACurrent
53217-203pravastatin sodiumpravastatin sodiumAidarex Pharmaceuticals LLCANDACurrent
53808-0685pravastatin sodiumpravastatin sodiumState of Florida DOH Central PharmacyANDACurrent
53808-0874pravastatin sodiumpravastatin sodiumState of Florida DOH Central PharmacyANDACurrent
53808-0875pravastatin sodiumpravastatin sodiumState of Florida DOH Central PharmacyANDACurrent
55154-4784pravastatin sodiumpravastatin sodiumCardinal HealthANDACurrent
55154-4982pravastatin sodiumpravastatin sodiumCardinal HealthANDACurrent
55154-4999pravastatin sodiumpravastatin sodiumCardinal HealthANDACurrent
61919-801Pravastatin SodiumPravastatin SodiumDirect_RxANDACurrent
61919-801PRAVASTATIN SODIUMPRAVASTATIN SODIUMDirect_RxANDACurrent
61919-801PRAVASTATIN SODIUMPRAVASTATIN SODIUMDirect_RxANDACurrent
63187-413pravastatin sodiumpravastatin sodiumProficient Rx LPANDACurrent
63187-413pravastatin sodiumpravastatin sodiumProficient Rx LPANDACurrent
63187-413pravastatin sodiumpravastatin sodiumProficient Rx LPANDACurrent
63187-415pravastatin sodiumpravastatin sodiumProficient Rx LPANDACurrent
63187-415pravastatin sodiumpravastatin sodiumProficient Rx LPANDACurrent
63187-415pravastatin sodiumpravastatin sodiumProficient Rx LPANDACurrent
63629-4588pravastatin sodiumpravastatin sodiumBryant Ranch PrepackANDACurrent
63629-4588pravastatin sodiumpravastatin sodiumBryant Ranch PrepackANDACurrent
63739-649pravastatin sodiumpravastatin sodiumMcKesson Corporation dba SKY PackagingANDACurrent
63739-649pravastatin sodiumpravastatin sodiumMcKesson Corporation dba SKY PackagingANDACurrent
63739-649pravastatin sodiumpravastatin sodiumMcKesson Corporation dba SKY PackagingANDACurrent
65084-649pravastatin sodiumpravastatin sodiumMcKesson Corporation dba RX PakANDACurrent
65084-649pravastatin sodiumpravastatin sodiumMcKesson Corporation dba RX PakANDACurrent
65841-739pravastatin sodiumpravastatin sodiumZydus Lifesciences LimitedANDACurrent
65841-739pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-739pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-739pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-740pravastatin sodiumpravastatin sodiumZydus Lifesciences LimitedANDACurrent
65841-740pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-740pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-740pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-741pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-741pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-741pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-741pravastatin sodiumpravastatin sodiumZydus Lifesciences LimitedANDACurrent
65841-742pravastatin sodiumpravastatin sodiumZydus Lifesciences LimitedANDACurrent
65841-742pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-742pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
65841-742pravastatin sodiumpravastatin sodiumCadila Healthcare LimitedANDACurrent
68071-3253pravastatin sodiumpravastatin sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4707pravastatin sodiumpravastatin sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4707pravastatin sodiumpravastatin sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4707pravastatin sodiumpravastatin sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68382-070pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals USA Inc.ANDACurrent
68382-070pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-070pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-071pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals USA Inc.ANDACurrent
68382-071pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-071pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-072pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals USA Inc.ANDACurrent
68382-072pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-072pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-073pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals USA Inc.ANDACurrent
68382-073pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-073pravastatin sodiumpravastatin sodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-0707pravastatin sodiumpravastatin sodiumREMEDYREPACK INC.ANDACurrent
70518-0707pravastatin sodiumpravastatin sodiumREMEDYREPACK INC.ANDACurrent
70518-2002pravastatin sodiumpravastatin sodiumREMEDYREPACK INC.ANDACurrent