FDA.reportPublic FDA data

Application 078702

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL4MGNoNo
002CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL8MGNoNo
003CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL16MGNoNo
004CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL32MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3224candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3224candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3224candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3225candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3225candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3225candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3231candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3231candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3231candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3232candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3232candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0378-3232candesartan cilexetilcandesartan cilexetilMylan Pharmaceuticals Inc.ANDACurrent
0781-5936Candesartan cilexetilCandesartan cilexetilSandoz IncANDACurrent
0781-5937Candesartan cilexetilCandesartan cilexetilSandoz IncANDACurrent
0781-5938Candesartan cilexetilCandesartan cilexetilSandoz IncANDACurrent
0781-5939Candesartan cilexetilCandesartan cilexetilSandoz IncANDACurrent
68151-3838Candesartan cilexetilCandesartan cilexetilCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31381ORIG2013-05-07