FDA.reportPublic FDA data

Application 074172

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0028NadololnadololMylan Pharmaceuticals Inc.ANDACurrent
0378-0028NadololnadololMylan Pharmaceuticals Inc.ANDACurrent
0378-1132NadololnadololMylan Pharmaceuticals Inc.ANDACurrent
0378-1132NadololnadololMylan Pharmaceuticals Inc.ANDACurrent
0378-1171NadololnadololMylan Pharmaceuticals Inc.ANDACurrent
0378-1171NadololnadololMylan Pharmaceuticals Inc.ANDACurrent
51079-812NadololnadololMylan Institutional Inc.ANDACurrent
51079-812NadololnadololMylan Institutional Inc.ANDACurrent
51079-813NadololnadololMylan Institutional Inc.ANDACurrent
51079-813NadololnadololMylan Institutional Inc.ANDACurrent
63629-6942NadololnadololBryant Ranch PrepackANDACurrent
63629-6942NadololnadololBryant Ranch PrepackANDACurrent