Application 203192

Type: ANDA
Sponsor: UNICHEM LABS LTD

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
A203192-001	ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203192-001	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 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	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203192-001	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203192-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203192-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203192-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Northwind Health Company, LLC	ffbd22eb-9df5-e0ad-e053-6294a90a7d4e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203192 application number: ANDA203192
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	c01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203192 application number: ANDA203192 ndc (product): 63629-9155
Alfuzosin hydrochloride	ALFUZOSIN HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	644295a9-75cb-4326-a71f-b0f4e0c4cf75	2022-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203192 application number: ANDA203192 ndc (product): 29300-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
63629-7907	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7907	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7907	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9155	Alfuzosin hydrochloride	Alfuzosin hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32391	ORIG	2016-01-29