FDA.reportPublic FDA data

Application 019962

Type
NDA
Sponsor
TOPROL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPROL-XLMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATEYesYes
002TOPROL-XLMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATEYesNo
003TOPROL-XLMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATEYesYes
004TOPROL-XLMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-1088TOPROLMetoprolol succinateAstraZeneca Pharmaceuticals LPNDACurrent
0186-1090TOPROLMetoprolol succinateAstraZeneca Pharmaceuticals LPNDACurrent
0186-1092TOPROLMetoprolol succinateAstraZeneca Pharmaceuticals LPNDACurrent
0186-1094TOPROLMetoprolol succinateAstraZeneca Pharmaceuticals LPNDACurrent
0527-2600METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2600METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2601METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2601METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2602METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2602METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2603METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2603METOPROLOL SUCCINATEMetoprolol succinateLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0615-8024METOPROLOL SUCCINATEMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsNDA AUTHORIZED GENERICCurrent
0615-8025METOPROLOL SUCCINATEMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsNDA AUTHORIZED GENERICCurrent
49884-404METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-405METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-406METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-825METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-826METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-827METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-828METOPROLOL SUCCINATEMetoprolol succinatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
50090-2296METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2296METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED Current
50090-2296METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2297METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED Current
50090-2311METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2311METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED Current
50090-2311METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3746METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3746METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3808METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3808METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3808METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3847METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3847METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3847METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3847METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4902METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4904METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5053METOPROLOL SUCCINATEMetoprolol succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50816-025METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-025METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-025METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-025METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-025METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-050METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-050METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-050METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-050METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-050METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-100METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-100METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-100METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-100METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-100METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-200METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-200METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-200METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-200METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
50816-200METOPROLOL SUCCINATEMetoprolol succinateNew American TherapeuticsNDA AUTHORIZED GENERICCurrent
55154-9609TOPROLMetoprolol succinateCardinal HealthNDACurrent
63629-3636TOPROLMetoprolol succinateBryant Ranch PrepackNDACurrent
63629-3636TOPROLMetoprolol succinateBryant Ranch PrepackNDACurrent
63629-6531METOPROLOL SUCCINATEMetoprolol succinateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6531METOPROLOL SUCCINATEMetoprolol succinateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6762METOPROLOL SUCCINATEMetoprolol succinateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6762METOPROLOL SUCCINATEMetoprolol succinateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6762METOPROLOL SUCCINATEMetoprolol succinateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6762METOPROLOL SUCCINATEMetoprolol succinateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
67544-282TOPROLMetoprolol succinateAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-491TOPROLMetoprolol succinateAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-555TOPROLMetoprolol succinateAphena Pharma Solutions - Tennessee, LLCNDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent
70347-025TOPROLMetoprolol succinateAralez Pharmaceuticals US Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73748SUPPL 2023-03-14
73747SUPPL 2023-03-14
73746SUPPL 2023-03-14
73745SUPPL 2023-03-14
71222SUPPL2022-06-07
71201SUPPL2022-06-02
69871SUPPL2022-01-13
69866SUPPL2022-01-13
34159SUPPL2014-05-12
19908SUPPL2014-05-08
1868SUPPL2012-11-05
34158SUPPL2012-11-02
12108SUPPL2010-03-26
19906SUPPL2010-03-24
19907SUPPL2010-01-26
12109SUPPL2010-01-20
34157SUPPL2009-03-02
1867SUPPL2009-03-02
12107SUPPL2008-02-25
19905SUPPL2008-02-19
34156SUPPL2007-07-24
1866SUPPL2007-07-24
19904SUPPL2007-03-23
34155SUPPL2006-08-04
19903SUPPL2006-08-04
19902SUPPL2006-05-05
41109SUPPL2005-07-15
41108SUPPL2005-07-15
20435SUPPL2005-07-15
20434SUPPL2005-07-15
19901SUPPL2005-04-12
34154SUPPL2005-02-17
1865SUPPL2005-02-17
1864SUPPL2003-01-30
41111SUPPL2002-05-30
19900SUPPL2002-03-05
41110SUPPL2000-07-20
19899SUPPL2000-07-10
12106SUPPL2000-07-10
52041SUPPL1900-01-01
52039SUPPL1900-01-01
52038SUPPL1900-01-01
52037SUPPL1900-01-01