Application 079056

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079056-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL			2011-07-18

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 1 of 2 · 41 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	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079056-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2011-07-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A079056-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079056-001	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	d163369b-e44b-4591-b166-7ddd0c1c13c0	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	8811cb59-6826-41d5-ab68-567338a4b883	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	37e89394-af6e-4700-bfa8-2effba1a286b	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Northwind Health Company, LLC	f2f42c98-4118-5f70-e053-2a95a90add02	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Northwind Health Company, LLC	ffbd22eb-9df5-e0ad-e053-6294a90a7d4e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	43675e9d-a361-4109-9ae1-54d80580fbbd	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Northwind Health Company, LLC	f2a530bd-6a86-251d-e053-2995a90adac4	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Apotex Corp.	26fcc267-c8d7-e059-1bcf-830dded43690	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	3a541efa-9eed-4a27-b602-7999fc6f59aa	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	98fa10c2-7c12-44aa-9112-e2fd6fa71d06	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d2af616e-673a-4fdd-ace8-db2d0f154604	2024-01-19	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin Hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	f075a897-7bef-4799-b7e2-7e051c461443	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	644295a9-75cb-4326-a71f-b0f4e0c4cf75	2022-03-25	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride extended release	ALFUZOSIN HYDROCHLORIDE	Cipla USA Inc.	3cc028d5-309f-4ce3-a2d7-5804ab57677d	2020-10-01	Warnings, Adverse reactions	Name fallback generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	790fe381-4a83-402e-b6c0-2ecde9cac7a7	2017-12-19	Warnings, Adverse reactions	Name fallback brand name: Alfuzosin hydrochloride generic name: ALFUZOSIN HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31407	ORIG	2011-07-20