FDA.reportPublic FDA data

Application 207465

Type
ANDA
Sponsor
CIPLA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68001-469METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-469METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-469METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-470METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-470METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-470METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-471METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-471METOPROLOL SUCCINATEmetoprolol succinateBluePoint LaboratoriesANDACurrent
68071-2455METOPROLOL SUCCINATEmetoprolol succinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5282METOPROLOL SUCCINATEmetoprolol succinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5282METOPROLOL SUCCINATEmetoprolol succinateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8312METOPROLOL SUCCINATEmetoprolol succinatePreferred Pharmaceuticals Inc.ANDACurrent
69097-407METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-407METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-407METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-408METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-408METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-408METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-409METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-409METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
69097-409METOPROLOL SUCCINATEmetoprolol succinateCipla USA Inc.ANDACurrent
70518-2868METOPROLOL SUCCINATEmetoprolol succinateREMEDYREPACK INC.ANDACurrent
70518-2868METOPROLOL SUCCINATEmetoprolol succinateREMEDYREPACK INC.ANDACurrent