Application 075646

Type: ANDA
Sponsor: YAOPHARMA CO LTD

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
A075646-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18
A075646-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18
A075646-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18
A075646-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18

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 2 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075646-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	2000-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075646-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	2000-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075646-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	2000-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075646-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	2000-10-18	`4b0b4de00fa7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxazosin mesylate	DOXAZOSIN MESYLATE	Chartwell RX, LLC	a7f589b0-eebb-48cb-912f-a4bd956e4dcb	2023-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075646 application number: ANDA075646

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30973	ORIG	2000-10-18