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 1.

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021269-001	CARDURA XL	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-02-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021269-002	CARDURA XL	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2005-02-22	`782e0a99824c…`

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

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