Application 209013

Type: ANDA
Sponsor: UPSHER SMITH LABS

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
A209013-001	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17
A209013-002	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17
A209013-003	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17
A209013-004	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209013-001	AB
A209013-002	AB
A209013-003	AB
A209013-004	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	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209013-001	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2018-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209013-002	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209013-003	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209013-004	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET / ORAL	AB	2018-04-17	`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	A209013-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209013-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209013-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209013-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209013-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209013-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209013-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209013-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209013-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209013-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209013-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209013-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209013-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209013-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209013-004	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 · 6 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	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	Northwind Health Company, LLC	f6c9856e-9154-f349-e053-6294a90a9f2c	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	Upsher-Smith laboratories, LLC	b5d1c604-ce3b-4973-845f-9db267a945cd	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013 ndc (product): 0832-1358 ndc (product): 0832-0357 ndc (product): 0832-1359 ndc (product): 0832-0356
Doxazosin	DOXAZOSIN MESYLATE	A-S Medication Solutions	b4c974ad-cbd6-4811-ab48-461e7ffa99f7	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013 ndc (product): 50090-6298
Doxazosin	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	0d9df8e9-f823-4ff8-a5fe-0309dd132b04	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013
Doxazosin	DOXAZOSIN MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	6b74b18f-b89a-4109-a29e-c4fa65a3c5ee	2020-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209013 application number: ANDA209013 ndc (product): 71610-482

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-0356	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-0356	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-0356	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-0357	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-0357	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-0357	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-1358	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-1358	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-1358	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-1359	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-1359	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
0832-1359	Doxazosin	Doxazosin Mesylate	Upsher-Smith laboratories, LLC	ANDA	Current
50090-6298	Doxazosin	Doxazosin Mesylate	A-S Medication Solutions	ANDA	Current
71610-420	Doxazosin	Doxazosin Mesylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-420	Doxazosin	Doxazosin Mesylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-482	Doxazosin	Doxazosin Mesylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current