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 2 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	AvKARE	43bec742-fbc4-39af-e063-6294a90ac734	2025-11-16	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	AvPAK	62fa7fdf-c588-6f79-e053-2a91aa0a4c19	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f6b6aeab-bedd-4254-8811-4f65cf8a351f	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	18e9741b-969a-5a87-e063-6294a90a8851	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	6a2a4cc7-c88a-4555-a247-d1e63206ffc5	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	00bb2d71-1f21-494c-aa66-a82be3a0a8e6	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	1d70b04e-ca08-48d3-937b-eb701b40dd8a	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f185abfc-367d-45da-87c4-86d9f70bcd5d	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	82d65964-de00-42c2-baaa-cc3de744b8eb	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Ascend Laboratories, LLC	ed9988bc-0759-4c36-bee1-11b68dc1c84c	2025-08-04	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	American Health Packaging	8150a710-aee5-4841-ae1b-7d2e61281a8f	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	3533e74e-5706-f594-e063-6394a90ab8a7	2025-06-13	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	36b8c36f-22e5-40f5-a99a-411115f13df4	2025-05-23	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	35bbb655-19e2-00c2-e063-6394a90afbe3	2025-05-22	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	9108b999-4b99-469d-99a8-5ef0fa4ca00a	2025-03-28	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c3ae55dd-6a0e-4f3a-82b6-2448e0545550	2025-03-20	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	EXELAN PHARMACEUTICALS, INC.	db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	2025-03-01	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	cfd48327-a528-58cc-e053-2995a90a129f	2025-02-10	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b85769ba-814e-1adb-e053-2a95a90a0556	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Sandoz Inc	fb120098-b007-4a33-80b8-b7279c7668ee	2024-09-30	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