FDA.reportPublic FDA data

Application 203699

Type
ANDA
Sponsor
PHARMADAX INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60050-003Metoprolol SuccinateMetoprolol SuccinatePharmadax Inc.ANDACurrent
60050-004Metoprolol SuccinateMetoprolol SuccinatePharmadax Inc.ANDACurrent
60760-563Metoprolol SuccinateMetoprolol SuccinateST. MARY'S MEDICAL PARK PHARMACYANDACurrent
64679-848Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-848Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-849Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-849Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
70518-3545Metoprolol SuccinateMetoprolol SuccinateREMEDYREPACK INC.ANDACurrent
75834-292Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-292Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-293Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-293Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent