Application 020579

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLOMAX	TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	0.4MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020579-001	FLOMAX	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		RLD	1997-04-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL		RLD	1997-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL		RLD	1997-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL		RLD	1997-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL		RLD	1997-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL		RLD	1997-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL		RLD	1997-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020579-001	FLOMAX	0.4MG	CAPSULE / ORAL	AB	RLD, RS	1997-04-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020579-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020579-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020579-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020579-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020579-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020579-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020579-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020579-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020579-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020579-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020579-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020579-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020579-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020579-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020579-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020579-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020579-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020579-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020579-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020579-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020579-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020579-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020579-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020579-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020579-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020579-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020579-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020579-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020579-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020579-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020579-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020579-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020579-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020579-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020579-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020579-001	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 3 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	503d080c-9db3-434a-add6-c7d0e5a0ab2e	2024-09-19	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Zydus Lifesciences Limited	276c7e26-f86a-46b9-b626-ceef76b729a4	2024-08-12		Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	985871d9-81e2-5fda-e053-2995a90a0338	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	87618dfd-eae4-2532-e053-2a95a90a10a0	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6cb939a6-2bc6-5ca0-e053-2991aa0a4e69	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	199a74b0-47bf-012d-e063-6394a90ac375	2024-05-29	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	58bdac81-680a-4fd2-8f05-dd5b86553569	2024-04-05	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	9631351f-66f4-45e5-a866-1e59311bd4d7	2024-01-31	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	8cb27f78-2d5d-4640-b7b5-ed06973c8133	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NorthStar Rx LLC	7ab14f88-414a-448f-b7bf-de8c9e1b1eb3	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	300be29a-c56d-4daa-ba89-f207c281ea20	2023-11-08	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	3a05970e-6c34-4dff-9fd7-dde8ce60f280	2023-10-03	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e0ad49c7-f57c-45c6-9084-16d8b79c8f87	2023-09-26	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	74a8ef78-908f-4671-91a3-ec3a044aabf2	2023-09-21	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	12ba3063-a134-41e2-8447-45933d4f0f58	2023-09-18	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c963384e-eb50-4462-9aea-ed9d26d267d6	2023-08-14	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	25d5ceab-a04b-4cf0-bc48-3d0c6d8af006	2023-01-01	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Macleods Pharmaceuticals Limited	2912fbbc-89bf-4bf0-86fe-bd98f3168e84	2022-11-30	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	58cba3d8-bb57-4e64-a191-dc050904c896	2022-08-01	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	7275902e-6832-4e71-997a-d1f7fc1c6a11	2022-07-01	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0024-5837	FLOMAX	tamsulosin hydrochloride	sanofi-aventis U.S. LLC	NDA	Current
0024-5837	FLOMAX	tamsulosin hydrochloride	sanofi-aventis U.S. LLC	NDA	Current
0024-5837	FLOMAX	tamsulosin hydrochloride	sanofi-aventis U.S. LLC	NDA	Current
0597-0058	Flomax	tamsulosin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0058	Flomax	tamsulosin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0058	Flomax	tamsulosin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
63629-3384	Flomax	tamsulosin hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-3384	Flomax	tamsulosin hydrochloride	Bryant Ranch Prepack	NDA	Current
67296-1803	FLOMAX	tamsulosin hydrochloride	RedPharm Drug, Inc.	NDA	Current
67296-1803	FLOMAX	tamsulosin hydrochloride	RedPharm Drug, Inc.	NDA	Current
70518-0518	Flomax	tamsulosin hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0518	Flomax	tamsulosin hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57514	SUPPL	2019-02-13
57343	SUPPL	2019-01-25
2779	SUPPL	2014-10-22
34879	SUPPL	2014-10-21
34878	SUPPL	2014-07-24
25225	SUPPL	2014-07-24
12770	SUPPL	2011-07-27
2778	SUPPL	2011-07-27
41443	ORIG	2010-03-16
12769	SUPPL	2010-01-04
25224	SUPPL	2009-12-29
2777	SUPPL	2009-11-19
12768	SUPPL	2009-10-30
52931	SUPPL	2009-09-17
52930	SUPPL	2009-09-17
52929	SUPPL	2009-09-17
52355	SUPPL	2009-09-17
52354	SUPPL	2009-09-17
52353	SUPPL	2009-09-17
52352	SUPPL	2009-09-17
25223	SUPPL	2008-12-04
2776	SUPPL	2008-05-05
25222	SUPPL	2007-02-23
12767	SUPPL	2007-02-21
12766	SUPPL	2007-01-16
2775	SUPPL	2007-01-16
2774	SUPPL	2005-10-25
34877	SUPPL	2005-10-24