Application 090408

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	0.4MG	No	No

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
A090408-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL			2010-04-27

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090408-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090408-001	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A090408-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090408-001	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 4 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	Proficient Rx LP	bf583b4a-a99c-4e18-a6d1-8609b5db1a3a	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d742707b-4c17-4b08-a9d0-491ba2bf6415	2020-12-31	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	06b44e53-c6e7-4e12-a8fd-572d092cfa70	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride 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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2500	Tamsulosin Hydrochloride	tamsulosin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7607	Tamsulosin Hydrochloride	tamsulosin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-703	Tamsulosin Hydrochloride	tamsulosin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-294	Tamsulosin Hydrochloride	tamsulosin hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5359	Tamsulosin Hydrochloride	tamsulosin hydrochloride	Cardinal Health	ANDA	Current
55154-5359	Tamsulosin Hydrochloride	tamsulosin hydrochloride	Cardinal Health	ANDA	Current