FDA.reportPublic FDA data

Application 077316

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
43353-132CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-133CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-156CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-160CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-771CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-771CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-771CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-930CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-930CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-930CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-931CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-931CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-931CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-932CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-932CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-932CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51655-002CarvedilolCarvedilolNorthwind PharmaceuticalsANDACurrent
55154-5675CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5677CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31222ORIG2007-09-07