FDA.reportPublic FDA data

Application 075509

Type
ANDA
Sponsor
MYLAN

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
0378-4021Doxazosindoxazosin mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-4022Doxazosindoxazosin mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-4024Doxazosindoxazosin mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-4028Doxazosindoxazosin mesylateMylan Pharmaceuticals Inc.ANDACurrent
0615-5536DoxazosinDoxazosin mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5537DoxazosinDoxazosin mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6570DoxazosinDoxazosin mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6571DoxazosinDoxazosin mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
33261-658Doxazosindoxazosin mesylateAidarex Pharmaceuticals LLCANDACurrent
43353-647Doxazosindoxazosin mesylateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-648Doxazosindoxazosin mesylateAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-957Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-957Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-957Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-958Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-958Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-958Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-959Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-959Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
51079-959Doxazosindoxazosin mesylateMylan Institutional Inc.ANDACurrent
55154-5659DoxazosindoxazosinCardinal HealthANDACurrent
55154-5659DoxazosindoxazosinCardinal HealthANDACurrent
55289-022Doxazosindoxazosin mesylatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-022Doxazosindoxazosin mesylatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-600Doxazosindoxazosin mesylatePD-Rx Pharmaceuticals, InANDACurrent
55289-600Doxazosindoxazosin mesylatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-600Doxazosindoxazosin mesylatePD-Rx Pharmaceuticals, Inc.ANDACurrent
67544-273Doxazosindoxazosin mesylateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30918ORIG2000-10-19