FDA.report

Application 203325

Type
ANDA
Sponsor
ZYDUS PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTANTELMISARTANTABLET;ORAL20MGNoNo
002TELMISARTANTELMISARTANTABLET;ORAL40MGNoNo
003TELMISARTANTELMISARTANTABLET;ORAL80MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-804telmisartantelmisartanZydus Lifesciences LimitedANDACurrent
65841-804telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-804telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-804telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-805telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-805telmisartantelmisartanZydus Lifesciences LimitedANDACurrent
65841-805telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-805telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-806telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-806telmisartantelmisartanZydus Lifesciences LimitedANDACurrent
65841-806telmisartantelmisartanCadila Healthcare LimitedANDACurrent
65841-806telmisartantelmisartanCadila Healthcare LimitedANDACurrent
68382-471telmisartantelmisartanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-471telmisartantelmisartanZydus Pharmaceuticals USA Inc.ANDACurrent
68382-471telmisartantelmisartanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-472telmisartantelmisartanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-472telmisartantelmisartanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-472telmisartantelmisartanZydus Pharmaceuticals USA Inc.ANDACurrent
68382-473telmisartantelmisartanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-473telmisartantelmisartanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-473telmisartantelmisartanZydus Pharmaceuticals USA Inc.ANDACurrent
70518-3300telmisartantelmisartanREMEDYREPACK INC.ANDACurrent
70518-3300telmisartantelmisartanREMEDYREPACK INC.ANDACurrent
71335-0875telmisartantelmisartanBryant Ranch PrepackANDACurrent
71335-0875telmisartantelmisartanBryant Ranch PrepackANDACurrent
71335-0875telmisartantelmisartanBryant Ranch PrepackANDACurrent