Home Applications 078938 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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A078938-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078938-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 3 · 59 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tamsulosin Hydrochloride TAMSULOSIN HYDROCHLORIDE Major Pharmaceuticals f8302a6e-b8da-4931-a279-b49e37943816 2026-09-01 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 2026-08-25 Warnings, Adverse reactions Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE 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 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 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 AvPAK 62fa7fdf-c588-6f79-e053-2a91aa0a4c19 2025-10-22 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 · 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