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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A208719-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-07-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208719-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2017-07-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208719-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2017-07-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208719-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2017-07-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208719-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208719-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208719-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208719-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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