Home Applications 078015 Application 078015
Type ANDA
Sponsor SANDOZ 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 A078015-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078015-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 e64feba35796…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-2076 tamsulosin hydrochloride tamsulosin hydrochloride Sandoz Inc ANDA Current 0781-2076 tamsulosin hydrochloride tamsulosin hydrochloride Sandoz Inc ANDA Current 0781-2076 tamsulosin hydrochloride tamsulosin hydrochloride Sandoz Inc ANDA Current 0904-6401 tamsulosin hydrochloride tamsulosin hydrochloride Major Pharmaceuticals ANDA Current 0904-6401 tamsulosin hydrochloride tamsulosin hydrochloride Major Pharmaceuticals ANDA Current 43353-013 tamsulosin hydrochloride tamsulosin hydrochloride Aphena Pharma Solutions - Tennessee, LLC ANDA Current 55154-7649 tamsulosin hydrochloride tamsulosin hydrochloride Cardinal Health 107, LLC ANDA Current 55154-7649 tamsulosin hydrochloride tamsulosin hydrochloride Cardinal Health ANDA Current 55154-7649 tamsulosin hydrochloride tamsulosin hydrochloride Cardinal Health ANDA Current 55154-7649 tamsulosin hydrochloride tamsulosin hydrochloride Cardinal Health ANDA Current 70518-1999 tamsulosin hydrochloride tamsulosin hydrochloride REMEDYREPACK INC. ANDA Current 70518-1999 tamsulosin hydrochloride tamsulosin hydrochloride REMEDYREPACK INC. ANDA Current 70518-1999 tamsulosin hydrochloride tamsulosin hydrochloride REMEDYREPACK INC. ANDA Current