Application 076161

Type: ANDA
Sponsor: DAVA PHARMS INC

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 44.

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	Approval date
A076161-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10
A076161-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10
A076161-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10
A076161-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076161-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2004-06-10	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076161-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2004-06-10	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076161-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2004-06-10	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076161-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2004-06-10	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076161-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076161-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076161-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076161-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076161-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076161-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076161-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076161-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076161-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076161-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076161-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076161-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076161-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076161-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076161-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076161-004	AB	1	`ea99ee380514…`

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 MESYLATE	Bryant Ranch Prepack	277c3278-4fe2-47ac-9115-15b417325ffd	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	e2f5d7d2-21aa-4921-8035-da945d3c565c	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	8641cdb1-dc16-4a13-8a84-bc8f6d58b4d4	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Northwind Health Company, LLC	f6c9856e-9154-f349-e053-6294a90a9f2c	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	7aeaa0e1-136c-444d-b66c-7a5a96fb3022	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin mesylate	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	445dc831-1960-4b25-e063-6294a90a6efd	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Doxazosin mesylate generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Upsher-Smith laboratories, LLC	b5d1c604-ce3b-4973-845f-9db267a945cd	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Bryant Ranch Prepack	d42d2691-f25d-4dfc-99d0-3286d71480a4	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	57f4a953-ad23-4a44-9956-c48aa5927132	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	b4c974ad-cbd6-4811-ab48-461e7ffa99f7	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	9b6170e7-814a-46ef-b068-cf3e6508d5e1	2024-10-21	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Aurobindo Pharma Limited	93f2d724-5a54-4721-b04a-e46bc764607b	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin mesylate	DOXAZOSIN MESYLATE	Mylan Pharmaceuticals Inc.	2e524986-7903-416f-b2b8-d27295103e75	2024-03-11	Warnings, Adverse reactions	Name fallback brand name: Doxazosin mesylate generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	0d9df8e9-f823-4ff8-a5fe-0309dd132b04	2024-02-06	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin Mesylate	DOXAZOSIN MESYLATE	Unichem Pharmaceuticals (USA), Inc.	44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f	2024-01-23	Warnings, Adverse reactions	Name fallback brand name: Doxazosin Mesylate generic name: DOXAZOSIN MESYLATE
Doxazosin mesylate	DOXAZOSIN MESYLATE	Chartwell RX, LLC	a7f589b0-eebb-48cb-912f-a4bd956e4dcb	2023-06-09	Warnings, Adverse reactions	Name fallback brand name: Doxazosin mesylate generic name: DOXAZOSIN MESYLATE
Cardura XL	DOXAZOSIN MESYLATE	Viatris Specialty LLC	355bcdce-0481-48ba-8ebd-2009106aaf77	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Teva Pharmaceuticals USA, Inc.	0aaa68a7-f73b-46d8-860f-a76d96897489	2021-11-30	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE
Doxazosin	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	6b74b18f-b89a-4109-a29e-c4fa65a3c5ee	2020-12-10	Warnings, Adverse reactions	Name fallback generic name: DOXAZOSIN MESYLATE

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-292	Doxazosin Mesylate	Doxazosin Mesylate	Blenheim Pharmacal, Inc.	ANDA	Current
10544-629	Doxazosin Mesylate	Doxazosin Mesylate	Blenheim Pharmacal, Inc.	ANDA	Current
43353-646	Doxazosin Mesylate	Doxazosin Mesylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-739	Doxazosin Mesylate	Doxazosin Mesylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-740	Doxazosin Mesylate	Doxazosin Mesylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0735	Doxazosin Mesylate	Doxazosin Mesylate	A-S Medication Solutions	ANDA	Current
50090-1591	Doxazosin Mesylate	Doxazosin Mesylate	A-S Medication Solutions	ANDA	Current
53808-1017	Doxazosin mesylate	doxazosin mesylate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1107	Doxazosin Mesylate	Doxazosin Mesylate	DOH CENTRAL PHARMACY	ANDA	Current
60429-953	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-953	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-954	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-954	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-955	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-955	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-956	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
60429-956	Doxazosin Mesylate	Doxazosin Mesylate	Golden State Medical Supply, Inc.	ANDA	Current
67253-380	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-380	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-381	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-381	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-382	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-382	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-383	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
67253-383	Doxazosin Mesylate	Doxazosin Mesylate	Par Pharmaceutical	ANDA	Current
68258-6099	Doxazosin Mesylate	Doxazosin Mesylate	Dispensing Solutions, Inc.	ANDA	Current
70518-0184	Doxazosin Mesylate	Doxazosin Mesylate	REMEDYREPACK INC.	ANDA	Current