Application 075580

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	TABLET;ORAL	EQ 1MG BASE	No	No
002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	TABLET;ORAL	EQ 2MG BASE	No	No
003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	TABLET;ORAL	EQ 4MG BASE	No	No
004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	TABLET;ORAL	EQ 8MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075580-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18
A075580-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18
A075580-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18
A075580-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075580-001	AB
A075580-002	AB
A075580-003	AB
A075580-004	AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075580-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075580-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075580-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075580-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075580-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075580-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075580-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075580-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075580-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075580-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075580-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075580-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075580-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075580-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075580-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075580-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075580-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075580-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075580-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075580-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075580-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075580-004	AB	1	`5bbf6a4d5a75…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	30a6bb83-f91b-4c4f-a849-4f2be3735a0e	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Major Pharmaceuticals	3354196f-bbcf-4bc5-94f6-e6e8e132acb1	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	A-S Medication Solutions	bfea0b5b-9354-490f-88ff-008134077d24	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	bf2f7b41-f14d-4fcd-8db3-f507ca6ff78b	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	PD-Rx Pharmaceuticals, Inc.	2ea9bb6b-a4f0-496a-b27b-4454167a4b70	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Cardinal Health 107, LLC	08521333-ff21-45ad-b99e-1f43d945d24d	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Preferred Pharmaceuticals Inc.	2110eec5-949d-4718-ad6d-3629e5db8a07	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Preferred Pharmaceuticals Inc.	e046e0b7-f510-4318-9884-034d683864d4	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	AvPAK	de9ab9a4-d8b8-8b36-e053-2a95a90aaa35	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	AvKARE	e3d381c1-3b2f-af70-f4e6-08d6202eed25	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	54116886-ea5e-5320-e054-00144ff8d46c	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	54549d19-6311-4dbb-8622-fd3e5440551a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Northwind Health Company, LLC	f306adae-a2fe-5477-e053-2995a90a7838	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	American Health Packaging	3f4dc1a7-05e6-41d7-908c-30ce2677d87b	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	2e5cd8cb-7d43-e7af-e063-6294a90a310e	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	505d3c4c-5506-72cc-e054-00144ff88e88	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Proficient Rx LP	1d8ff659-8129-4dca-9e8f-13b97240d1e1	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	f1dc70f6-4329-46da-8990-7bd6eec9d37d	2021-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580 ndc (product): 71610-153 ndc (product): 71610-160
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	7e547752-a53a-4ad9-b70e-7cc2a1dd5d5d	2018-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075580 application number: ANDA075580 ndc (product): 71610-043

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 2 of 2 · 91 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70934-728	Doxazosin	Doxazosin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-921	Doxazosin	Doxazosin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0002	Doxazosin	Doxazosin	Bryant Ranch Prepack	ANDA	Current
71335-0002	Doxazosin	Doxazosin	Bryant Ranch Prepack	ANDA	Current
71335-0002	Doxazosin	Doxazosin	Bryant Ranch Prepack	ANDA	Current
71335-0002	Doxazosin	Doxazosin	Bryant Ranch Prepack	ANDA	Current
71610-043	Doxazosin	Doxazosin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-153	Doxazosin	Doxazosin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-153	Doxazosin	Doxazosin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-160	Doxazosin	Doxazosin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-160	Doxazosin	Doxazosin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8725	ORIG	2004-06-02
8724	ORIG	2000-10-18