FDA.reportPublic FDA data

Application 021269

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARDURA XLDOXAZOSIN MESYLATETABLET, EXTENDED RELEASE;ORALEQ 4MG BASEYesNo
002CARDURA XLDOXAZOSIN MESYLATETABLET, EXTENDED RELEASE;ORALEQ 8MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-2040CarduradoxazosinRoerigNDACurrent
0049-2040CarduradoxazosinRoerigNDACurrent
0049-2040CarduradoxazosinRoerigNDACurrent
0049-2080CarduradoxazosinRoerigNDACurrent
0049-2080CarduradoxazosinRoerigNDACurrent
0049-2080CarduradoxazosinRoerigNDACurrent
0049-2710Carduradoxazosin mesylateRoerigNDACurrent
0049-2710Carduradoxazosin mesylateRoerigNDACurrent
0049-2710Carduradoxazosin mesylateRoerigNDACurrent
0049-2710Carduradoxazosin mesylateRoerigNDACurrent
0049-2720Carduradoxazosin mesylateRoerigNDACurrent
0049-2720Carduradoxazosin mesylateRoerigNDACurrent
0049-2720Carduradoxazosin mesylateRoerigNDACurrent
0049-2720Carduradoxazosin mesylateRoerigNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67911SUPPL2021-06-28
67884SUPPL2021-06-24
47446SUPPL2017-03-03
47362SUPPL2017-02-28
14818SUPPL2015-06-11
4853SUPPL2015-06-10
36528SUPPL2011-07-12
27302SUPPL2011-07-12
4852SUPPL2010-03-22
14817SUPPL2010-03-17
21561ORIG2008-10-02
4851SUPPL2006-04-05
27301ORIG2005-02-23
14816ORIG2005-02-23