Application 207405

Type: ANDA
Sponsor: ALKEM LABS LTD

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 42.

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
A207405-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2017-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207405-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207405-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207405-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207405-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207405-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207405-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207405-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207405-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207405-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207405-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207405-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207405-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207405-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207405-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207405-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207405-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207405-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207405-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207405-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207405-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207405-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207405-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207405-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207405-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207405-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207405-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207405-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207405-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207405-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207405-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207405-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207405-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207405-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207405-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207405-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207405-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207405-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207405-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207405-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207405-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207405-001	AB	1	`e64feba35796…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Chartwell RX, LLC	14db58df-7584-410b-8cf4-4b928dada859	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	AvPAK	62fa7fdf-c588-6f79-e053-2a91aa0a4c19	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 50268-740
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	18e9741b-969a-5a87-e063-6294a90a8851	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f185abfc-367d-45da-87c4-86d9f70bcd5d	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 71335-1538
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Ascend Laboratories, LLC	ed9988bc-0759-4c36-bee1-11b68dc1c84c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 67877-450
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	3a05970e-6c34-4dff-9fd7-dde8ce60f280	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 50090-3646
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	74a8ef78-908f-4671-91a3-ec3a044aabf2	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 50090-4906
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	06b44e53-c6e7-4e12-a8fd-572d092cfa70	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 71205-217

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3646	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3646	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3646	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4906	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-740	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	AvPAK	ANDA	Current
50268-740	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	AvPAK	ANDA	Current
50268-740	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	AvPAK	ANDA	Current
55700-670	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-670	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
67296-1646	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	RedPharm Drug. Inc.	ANDA	Current
67296-1646	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	RedPharm Drug. Inc.	ANDA	Current
67877-450	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-450	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-450	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
70518-1208	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1252	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1252	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-771	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-217	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-217	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-217	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1538	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Bryant Ranch Prepack	ANDA	Current