FDA.reportPublic FDA data

Application 207760

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BOSENTANBOSENTANTABLET;ORAL62.5MGNoNo
002BOSENTANBOSENTANTABLET;ORAL125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-446BosentanBosentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-446BosentanBosentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-446BosentanBosentanZydus Pharmaceuticals USA Inc.ANDACurrent
68382-447BosentanBosentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-447BosentanBosentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-447BosentanBosentanZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1017BosentanBosentanCadila Healthcare LimitedANDACurrent
70771-1017BosentanBosentanZydus Lifesciences LimitedANDACurrent
70771-1017BosentanBosentanCadila Healthcare LimitedANDACurrent
70771-1017BosentanBosentanCadila Healthcare LimitedANDACurrent
70771-1018BosentanBosentanCadila Healthcare LimitedANDACurrent
70771-1018BosentanBosentanZydus Lifesciences LimitedANDACurrent
70771-1018BosentanBosentanCadila Healthcare LimitedANDACurrent
70771-1018BosentanBosentanCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76402ORIG 2023-11-06