Application 075536

Type: ANDA
Sponsor: TEVA

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 1.

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
A075536-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18
A075536-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18
A075536-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18
A075536-004	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
A075536-001	AB
A075536-002	AB
A075536-003	AB
A075536-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-004	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	A075536-001	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	A075536-002	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	A075536-003	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	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-004	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	A075536-001	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	A075536-002	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	A075536-003	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	A075536-004	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	A075536-001	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	A075536-002	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	A075536-003	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	A075536-004	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	A075536-001	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	A075536-002	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	A075536-003	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	A075536-004	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	A075536-001	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	A075536-002	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	A075536-003	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	A075536-004	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	A075536-001	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	A075536-002	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	A075536-003	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	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075536-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2000-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075536-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2000-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075536-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2000-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075536-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2000-10-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075536-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075536-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075536-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075536-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075536-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075536-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075536-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075536-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075536-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075536-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075536-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075536-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075536-004	AB	1	`d06236e962d9…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	e2f5d7d2-21aa-4921-8035-da945d3c565c	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	7aeaa0e1-136c-444d-b66c-7a5a96fb3022	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	d42d2691-f25d-4dfc-99d0-3286d71480a4	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	57f4a953-ad23-4a44-9956-c48aa5927132	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	9b6170e7-814a-46ef-b068-cf3e6508d5e1	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536 ndc (product): 50090-3143
Doxazosin	DOXAZOSIN MESYLATE	Teva Pharmaceuticals USA, Inc.	0aaa68a7-f73b-46d8-860f-a76d96897489	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075536 application number: ANDA075536 ndc (product): 0093-2067 ndc (product): 0093-2069 ndc (product): 0093-2068 ndc (product): 0093-2070

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2067	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2067	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2067	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2067	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2068	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2068	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2068	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2068	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2069	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2069	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2069	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2069	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2070	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2070	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2070	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2070	Doxazosin	Doxazosin Mesylate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42254-075	Doxazosin	Doxazosin Mesylate	Rebel Distributors Corp	ANDA	Current
50090-3143	Doxazosin	Doxazosin Mesylate	A-S Medication Solutions	ANDA	Current
50090-3143	Doxazosin	Doxazosin Mesylate	A-S Medication Solutions	ANDA	Current
53808-0361	Doxazosin Mesylate	Doxazosin Mesylate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0362	Doxazosin Mesylate	Doxazosin Mesylate	State of Florida DOH Central Pharmacy	ANDA	Current
55700-648	Doxazosin	Doxazosin Mesylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68071-3331	Doxazosin	Doxazosin Mesylate	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-0839	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current
70518-0839	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1061	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1061	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1061	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1645	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1645	Doxazosin	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30926	ORIG	2004-06-02
8712	ORIG	2000-10-18