Application 078938

Type: ANDA
Sponsor: WOCKHARDT

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
A078938-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078938-001	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	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078938-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`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	A078938-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078938-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078938-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078938-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078938-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078938-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078938-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078938-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078938-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078938-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078938-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078938-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078938-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078938-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078938-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078938-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078938-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078938-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078938-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078938-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078938-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078938-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078938-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078938-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078938-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078938-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078938-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078938-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078938-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078938-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078938-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078938-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078938-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078938-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078938-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078938-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078938-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078938-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078938-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078938-001	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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e4202c52-be9d-41d9-b5ff-122740298544	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	REMEDYREPACK INC.	a608ddc8-fe42-484e-b61f-307c60151138	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	e9372720-bd02-e4a6-0afd-42fe0c661c00	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	REMEDYREPACK INC.	b30e2bde-b20e-4899-a100-f44170d8165b	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Cardinal Health 107, LLC	5ed219aa-cf65-457f-8570-d26b48edb240	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Coupler LLC	52bbe73b-43b6-3393-e063-6294a90a6dc6	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	59d0e07c-0018-4681-beb2-cb1c8e2637ee	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	St. Marys Medical Park Pharmacy	6142d7b6-e5ea-1af0-e053-2991aa0a00cd	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	DIRECT RX	7a420aca-31e6-8e0c-e053-2a91aa0a1be0	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: TAMSULOSIN HYDROCHLORIDE generic name: TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Direct_Rx	8de50eca-8cc5-082d-e053-2a95a90a346d	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: TAMSULOSIN HYDROCHLORIDE generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	fd73ddfd-3773-45b2-9795-9e58744a6803	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Redpharm Drug	4d481f6b-0232-d4af-e063-6394a90ad1af	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f543f5d1-3348-4066-99a4-7a00aee1530d	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Northwind Health Company, LLC	d9df4fe0-90ab-0d96-e053-2a95a90a5ff1	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	00097e78-9c04-4e62-8260-ddb50e9a6a93	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: tamsulosin hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Chartwell RX, LLC	14db58df-7584-410b-8cf4-4b928dada859	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Synthon Pharmaceuticals, Inc.	13a5032d-0be1-4001-916e-459f0b1a051d	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	AvKARE	43bec742-fbc4-39af-e063-6294a90ac734	2025-11-16	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Cardinal Health 107, LLC	0e3206ba-db3e-40b3-b46b-c7ae4703fdea	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE

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
10544-550	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Blenheim Pharmacal, Inc.	ANDA	Current
33261-839	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Aidarex Pharmaceuticals LLC	ANDA	Current
42254-012	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Rebel Distributors Corp	ANDA	Current
52959-034	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	H.J. Harkins Company, Inc.	ANDA	Current
55648-516	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	WOCKHARDT LIMITED	ANDA	Current
64679-516	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-516	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-516	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
68788-0816	Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Preferred Pharmaceuticals	ANDA	Current
70934-969	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current