Home Applications 021269 Application 021269
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARDURA XL DOXAZOSIN MESYLATE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE Yes No 002 CARDURA XL DOXAZOSIN MESYLATE TABLET, EXTENDED RELEASE;ORAL EQ 8MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021269-001 CARDURA XL DOXAZOSIN MESYLATE EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2005-02-22 N021269-002 CARDURA XL DOXAZOSIN MESYLATE EQ 8MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2005-02-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021269-001 CARDURA XL EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2005-02-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021269-002 CARDURA XL EQ 8MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2005-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021269-001 CARDURA XL EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2005-02-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021269-002 CARDURA XL EQ 8MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2005-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021269-001 CARDURA XL EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2005-02-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021269-002 CARDURA XL EQ 8MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2005-02-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021269-001 CARDURA XL EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2005-02-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021269-002 CARDURA XL EQ 8MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2005-02-22 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cardura XL DOXAZOSIN MESYLATE Viatris Specialty LLC 355bcdce-0481-48ba-8ebd-2009106aaf77 2023-05-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 021269 application number: NDA021269
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0049-2040 Cardura doxazosin Roerig NDA Current 0049-2040 Cardura doxazosin Roerig NDA Current 0049-2040 Cardura doxazosin Roerig NDA Current 0049-2080 Cardura doxazosin Roerig NDA Current 0049-2080 Cardura doxazosin Roerig NDA Current 0049-2080 Cardura doxazosin Roerig NDA Current 0049-2710 Cardura doxazosin mesylate Roerig NDA Current 0049-2710 Cardura doxazosin mesylate Roerig NDA Current 0049-2710 Cardura doxazosin mesylate Roerig NDA Current 0049-2710 Cardura doxazosin mesylate Roerig NDA Current 0049-2720 Cardura doxazosin mesylate Roerig NDA Current 0049-2720 Cardura doxazosin mesylate Roerig NDA Current 0049-2720 Cardura doxazosin mesylate Roerig NDA Current 0049-2720 Cardura doxazosin mesylate Roerig NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67911 SUPPL 2021-06-28 67884 SUPPL 2021-06-24 47446 SUPPL 2017-03-03 47362 SUPPL 2017-02-28 14818 SUPPL 2015-06-11 4853 SUPPL 2015-06-10 36528 SUPPL 2011-07-12 27302 SUPPL 2011-07-12 4852 SUPPL 2010-03-22 14817 SUPPL 2010-03-17 21561 ORIG 2008-10-02 4851 SUPPL 2006-04-05 27301 ORIG 2005-02-23 14816 ORIG 2005-02-23