Application 208719

Type: ANDA
Sponsor: ZYDUS PHARMS

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 42.

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
A208719-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07
A208719-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208719-001	AB
A208719-002	AB
A208719-003	AB
A208719-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208719-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208719-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208719-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208719-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208719-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208719-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208719-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208719-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208719-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208719-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208719-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208719-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208719-004	AB	1	`d8e5a09893c0…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin	DOXAZOSIN	REMEDYREPACK INC.	ec06f008-37a1-4757-a3ee-0b4720912bc4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals, Inc.	30b709d6-c438-c721-e063-6294a90abd61	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	NuCare Pharmaceuticals,Inc.	88efdfb0-710f-768a-e053-2995a90aede4	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719 ndc (product): 68071-4892
Doxazosin	DOXAZOSIN	Zydus Lifesciences Limited	ac889877-133c-4448-af5a-d77b3cbfe878	2024-11-28		Exact identifier application applno (ANDA): 208719 application number: ANDA208719 ndc (product): 70771-1112 ndc (product): 70771-1115 ndc (product): 70771-1114 ndc (product): 70771-1113
Doxazosin	DOXAZOSIN	A-S Medication Solutions	46b01b1d-c48a-4c36-bf3c-bba98066166c	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719 ndc (product): 50090-3927
Doxazosin	DOXAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	187bc51b-7a3a-5910-e063-6294a90aa888	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Bryant Ranch Prepack	6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719
Doxazosin	DOXAZOSIN	Zydus Pharmaceuticals USA Inc.	e4758bf9-b9d4-4268-beb8-0d7e06890895	2023-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208719 application number: ANDA208719 ndc (product): 68382-785 ndc (product): 68382-784 ndc (product): 68382-786 ndc (product): 68382-783

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3927	Doxazosin	Doxazosin	A-S Medication Solutions	ANDA	Current
50090-3987	Doxazosin	Doxazosin	A-S Medication Solutions	ANDA	Current
50090-4000	Doxazosin	Doxazosin	A-S Medication Solutions	ANDA	Current
50090-4000	Doxazosin	Doxazosin	A-S Medication Solutions	ANDA	Current
50090-4004	Doxazosin	Doxazosin	A-S Medication Solutions	ANDA	Current
68071-4892	Doxazosin	Doxazosin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4892	Doxazosin	Doxazosin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-783	Doxazosin	Doxazosin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-783	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-783	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-784	Doxazosin	Doxazosin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-784	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-784	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-785	Doxazosin	Doxazosin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-785	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-785	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-786	Doxazosin	Doxazosin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-786	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-786	Doxazosin	Doxazosin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1112	Doxazosin	Doxazosin	Zydus Lifesciences Limited	ANDA	Current
70771-1112	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1112	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1112	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1113	Doxazosin	Doxazosin	Zydus Lifesciences Limited	ANDA	Current
70771-1113	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1113	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1113	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1114	Doxazosin	Doxazosin	Zydus Lifesciences Limited	ANDA	Current
70771-1114	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1114	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1114	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1115	Doxazosin	Doxazosin	Zydus Lifesciences Limited	ANDA	Current
70771-1115	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1115	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current
70771-1115	Doxazosin	Doxazosin	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48944	ORIG	2017-07-11