FDA.reportPublic FDA data

Application 078332

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
0615-7944CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7944CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7945CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7945CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7946CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7946CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8018CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8018CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-184CarvedilolCarvedilolBlenheim Pharmacal, Inc.ANDACurrent
10544-187CarvedilolCarvedilolBlenheim Pharmacal, Inc.ANDACurrent
10544-190CarvedilolCarvedilolBlenheim Pharmacal, Inc.ANDACurrent
10544-191CarvedilolCarvedilolBlenheim Pharmacal, Inc.ANDACurrent
13107-142CarvedilolCarvedilolAurolife Pharma LLCANDACurrent
13107-143CarvedilolCarvedilolAurolife Pharma LLCANDACurrent
13107-144CarvedilolCarvedilolAurolife Pharma LLCANDACurrent
13107-145CarvedilolCarvedilolAurolife Pharma LLCANDACurrent
33261-975CarvedilolCarvedilolAidarex Pharmaceuticals LLCANDACurrent
33261-986CarvedilolCarvedilolAidarex Pharmaceuticals LLCANDACurrent
42254-162CarvedilolCarvedilolRebel Distributors CorpANDACurrent
43063-125CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-125CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-125CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-125CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-125CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-125CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-126CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-126CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-126CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-126CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-126CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-126CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, InANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-129CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-833CarvedilolCarvedilolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-832CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-837CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-838CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-874CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-1064CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1064CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1064CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1069CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1069CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1069CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1856CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1856CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-1856CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-2079CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50090-2079CarvedilolCarvedilolA-S Medication SolutionsANDACurrent
50436-2607CarvedilolCarvedilolUnit Dose ServicesANDACurrent
52343-026CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-026CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-027CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-027CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-028CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-028CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-029CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
52343-029CarvedilolCarvedilolACETRIS HEALTH, LLCANDACurrent
53002-1556CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1556CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1572CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1572CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1573CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1573CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1574CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9144ORIG2007-09-07