FDA.reportPublic FDA data

Application 208719

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 1MG BASENoNo
002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 2MG BASENoNo
003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 4MG BASENoNo
004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 8MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3927DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-3987DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-4000DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-4000DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-4004DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
68071-4892DoxazosinDoxazosinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4892DoxazosinDoxazosinNuCare Pharmaceuticals,Inc.ANDACurrent
68382-783DoxazosinDoxazosinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-783DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-783DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-784DoxazosinDoxazosinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-784DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-784DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-785DoxazosinDoxazosinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-785DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-785DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-786DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-786DoxazosinDoxazosinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-786DoxazosinDoxazosinZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1112DoxazosinDoxazosinZydus Lifesciences LimitedANDACurrent
70771-1112DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1112DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1112DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1113DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1113DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1113DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1113DoxazosinDoxazosinZydus Lifesciences LimitedANDACurrent
70771-1114DoxazosinDoxazosinZydus Lifesciences LimitedANDACurrent
70771-1114DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1114DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1114DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1115DoxazosinDoxazosinZydus Lifesciences LimitedANDACurrent
70771-1115DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1115DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent
70771-1115DoxazosinDoxazosinCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48944ORIG2017-07-11