FDA.report

Application 078227

Type
ANDA
Sponsor
SANDOZ

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CARVEDILOLCARVEDILOLTABLET;ORAL3.125MGNoNo
002CARVEDILOLCARVEDILOLTABLET;ORAL6.25MGNoNo
003CARVEDILOLCARVEDILOLTABLET;ORAL12.5MGNoNo
004CARVEDILOLCARVEDILOLTABLET;ORAL25MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-6583CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6584CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6585CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6586CarvedilolCarvedilolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-5221CarvedilolCarvedilolSandoz IncANDACurrent
0781-5221CarvedilolCarvedilolSandoz IncANDACurrent
0781-5222CarvedilolCarvedilolSandoz IncANDACurrent
0781-5222CarvedilolCarvedilolSandoz IncANDACurrent
0781-5223CarvedilolCarvedilolSandoz IncANDACurrent
0781-5223CarvedilolCarvedilolSandoz IncANDACurrent
0781-5224CarvedilolCarvedilolSandoz IncANDACurrent
0781-5224CarvedilolCarvedilolSandoz IncANDACurrent
0904-6300CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6300CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6301CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6301CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6302CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6302CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6303CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
0904-6303CarvedilolCarvedilolMajor PharmaceuticalsANDACurrent
55154-6883CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6883CarvedilolCarvedilolCardinal Health 107, LLCANDACurrent
55154-6883CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6883CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6884CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6884CarvedilolCarvedilolCardinal Health 107, LLCANDACurrent
55154-6884CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6884CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6885CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6885CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6885CarvedilolCarvedilolCardinal HealthANDACurrent
55154-6885CarvedilolCarvedilolCardinal Health 107, LLCANDACurrent
55154-7278CarvedilolCarvedilolCardinal Health 107, LLCANDACurrent
55154-7278CarvedilolCarvedilolCardinal HealthANDACurrent
55154-7278CarvedilolCarvedilolCardinal HealthANDACurrent
63629-6324CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
70934-653CarvedilolCarvedilolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
72189-372CarvedilolCarvedilolDirect_RxANDACurrent

Documents

DocumentSubmission typeDate
31347ORIG2007-09-07