FDA.reportPublic FDA data

Application 078276

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL5MGNoNo
002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL20MGNoNo
003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7012Olmesartan Medoxomilolmesartan medoxomilMylan Pharmaceuticals Inc.ANDACurrent
0378-7012Olmesartan Medoxomilolmesartan medoxomilMylan Pharmaceuticals Inc.ANDACurrent
0378-7112Olmesartan Medoxomilolmesartan medoxomilMylan Pharmaceuticals Inc.ANDACurrent
0378-7112Olmesartan Medoxomilolmesartan medoxomilMylan Pharmaceuticals Inc.ANDACurrent
0378-7124Olmesartan Medoxomilolmesartan medoxomilMylan Pharmaceuticals Inc.ANDACurrent
0378-7124Olmesartan Medoxomilolmesartan medoxomilMylan Pharmaceuticals Inc.ANDACurrent
42292-036Olmesartan Medoxomilolmesartan medoxomilMylan Institutional Inc.ANDACurrent
42292-037Olmesartan Medoxomilolmesartan medoxomilMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45728ORIG2016-10-31