FDA.reportPublic FDA data

Application 202397

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTANTELMISARTANTABLET;ORAL20MGNoNo
002TELMISARTANTELMISARTANTABLET;ORAL40MGNoNo
003TELMISARTANTELMISARTANTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2920TelmisartantelmisartanMylan Pharmaceuticals Inc.ANDACurrent
0378-2920TelmisartantelmisartanMylan Pharmaceuticals Inc.ANDACurrent
0378-2921TelmisartantelmisartanMylan Pharmaceuticals Inc.ANDACurrent
0378-2921TelmisartantelmisartanMylan Pharmaceuticals Inc.ANDACurrent
0378-2922TelmisartantelmisartanMylan Pharmaceuticals Inc.ANDACurrent
0378-2922TelmisartantelmisartanMylan Pharmaceuticals Inc.ANDACurrent
50090-5489TelmisartantelmisartanA-S Medication SolutionsANDACurrent
50090-5490TelmisartantelmisartanA-S Medication SolutionsANDACurrent
50090-5492TelmisartantelmisartanA-S Medication SolutionsANDACurrent