FDA.reportPublic FDA data

Application 211143

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATENoNo
002METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATENoNo
003METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATENoNo
004METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5720Metoprolol SuccinateMetoprolol Succinate ER TabletsA-S Medication SolutionsANDACurrent
50090-5722Metoprolol SuccinateMetoprolol Succinate ER TabletsA-S Medication SolutionsANDACurrent
50090-5733Metoprolol SuccinateMetoprolol Succinate ER TabletsA-S Medication SolutionsANDACurrent
55700-976Metoprolol SuccinateMetoprolol Succinate ER TabletsQuality Care Products, LLCANDACurrent
63629-8863Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8863Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8863Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8864Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8864Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8864Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8865Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8865Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8865Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8866Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8866Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-8866Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9167Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9167Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9167Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9168Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9168Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9168Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9169Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9169Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9169Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9170Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9170Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9170Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9171Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9171Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9171Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9172Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9172Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9172Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9173Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9173Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
63629-9173Metoprolol SuccinateMetoprolol Succinate ER TabletsBryant Ranch PrepackANDACurrent
67877-590Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-590Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-591Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-591Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-592Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-592Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-593Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
67877-593Metoprolol SuccinateMetoprolol Succinate ER TabletsAscend Laboratories, LLCANDACurrent
68001-500Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-500Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-500Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-500Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-501Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-501Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-501Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-501Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-502Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-502Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-502Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-502Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-503Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-503Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-503Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent
68001-503Metoprolol SuccinateMetoprolol Succinate ER TabletsBluePoint LaboratoriesANDACurrent