FDA.reportPublic FDA data

Application 040416

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JANTOVENWARFARIN SODIUMTABLET;ORAL1MGNoNo
002JANTOVENWARFARIN SODIUMTABLET;ORAL2MGNoNo
003JANTOVENWARFARIN SODIUMTABLET;ORAL2.5MGNoNo
004JANTOVENWARFARIN SODIUMTABLET;ORAL3MGNoNo
005JANTOVENWARFARIN SODIUMTABLET;ORAL4MGNoNo
006JANTOVENWARFARIN SODIUMTABLET;ORAL5MGNoNo
007JANTOVENWARFARIN SODIUMTABLET;ORAL6MGNoNo
008JANTOVENWARFARIN SODIUMTABLET;ORAL7.5MGNoNo
009JANTOVENWARFARIN SODIUMTABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0832-1211JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1212JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1213JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1214JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1215JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1216JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1217JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1218JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-1219JantovenWarfarin SodiumUpsher-Smith Laboratories, LLCANDACurrent
55154-5618JantovenWarfarin SodiumCardinal HealthANDACurrent
55154-5619JantovenWarfarin SodiumCardinal HealthANDACurrent
55154-5620JantovenWarfarin SodiumCardinal HealthANDACurrent
55154-5621JantovenWarfarin SodiumCardinal HealthANDACurrent