Application 079013

Type: ANDA
Sponsor: APOTEX INC

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 44.

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
A079013-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079013-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A079013-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079013-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079013-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079013-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A079013-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079013-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079013-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079013-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079013-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079013-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079013-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079013-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079013-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079013-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079013-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079013-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079013-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079013-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079013-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079013-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079013-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079013-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079013-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079013-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079013-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079013-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079013-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079013-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079013-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079013-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079013-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079013-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079013-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079013-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079013-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079013-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079013-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079013-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079013-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079013-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079013-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079013-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079013-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079013-001	AB	1	`3a93d1ddd44b…`

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
Alfuzosin Hydrochloride	ALFUZOSIN HYDROCHLORIDE	Apotex Corp.	26fcc267-c8d7-e059-1bcf-830dded43690	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079013 application number: ANDA079013 ndc (product): 60505-2850

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-110	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride	AvKARE, Inc.	ANDA	Current
60505-2850	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride	Apotex Corp.	ANDA	Current
60505-2850	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride	Apotex Corp.	ANDA	Current
60505-2850	Alfuzosin Hydrochloride	Alfuzosin Hydrochloride	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31403	ORIG	2011-07-20