FDA.reportPublic FDA data

Application 077614

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARVEDILOLCARVEDILOLTABLET;ORAL6.25MGNoNo
002CARVEDILOLCARVEDILOLTABLET;ORAL12.5MGNoNo
003CARVEDILOLCARVEDILOLTABLET;ORAL25MGNoNo
004CARVEDILOLCARVEDILOLTABLET;ORAL3.125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4171CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-4171CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
51655-029CARVEDILOLCARVEDILOLNorthwind Pharmaceuticals, LLCANDACurrent
51655-030CarvedilolCarvedilolNorthwind PharmaceuticalsANDACurrent
51655-397CarvedilolCarvedilolNorthwind PharmaceuticalsANDACurrent
51655-397CarvedilolCarvedilolNorthwind PharmaceuticalsANDACurrent
52959-466CarvedilolCarvedilolH.J. Harkins Company, Inc.ANDACurrent
53808-0220CarvedilolCarvedilolState of Florida DOH Central PharmacyANDACurrent
60760-494CarvedilolCarvedilolSt. Mary's Medical Park PharmacyANDACurrent
60760-582CarvedilolCarvedilolST. MARY'S MEDICAL PARK PHARMACYANDACurrent
63187-424CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-424CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-570CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-570CarvedilolCarvedilolProficient Rx LPANDACurrent
63629-4060CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-4060CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-4060CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-4070CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-8039CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-8039CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
65841-616CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-616CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-616CarvedilolCarvedilolZydus Lifesciences LimitedANDACurrent
65841-616CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-617CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-617CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-617CarvedilolCarvedilolZydus Lifesciences LimitedANDACurrent
65841-617CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-618CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-618CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-618CarvedilolCarvedilolZydus Lifesciences LimitedANDACurrent
65841-618CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-619CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-619CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
65841-619CarvedilolCarvedilolZydus Lifesciences LimitedANDACurrent
65841-619CarvedilolCarvedilolCadila Healthcare LimitedANDACurrent
68001-151CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-151CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-151CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-152CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-152CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-152CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-153CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-153CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-153CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-154CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-154CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68001-154CarvedilolCarvedilolBluePoint LaboratoriesANDACurrent
68071-2230CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2230CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2230CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2780CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3138CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3138CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4956CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4956CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68084-843CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68084-854CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68084-854CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68084-854CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68084-854CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68084-865CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68084-876CarvedilolCarvedilolAmerican Health PackagingANDACurrent
68382-092CarvedilolCarvedilolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-092CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-092CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-093CarvedilolCarvedilolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-093CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-093CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-094CarvedilolCarvedilolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-094CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-094CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-095CarvedilolCarvedilolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-095CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-095CarvedilolCarvedilolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68645-350CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-350CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-350CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-351CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-351CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31265ORIG2007-09-07