Home Applications 020579 Application 020579
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLOMAX TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Yes Yes
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 N020579-001 FLOMAX TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL RLD 1997-04-15
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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL RLD 1997-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL RLD 1997-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL RLD 1997-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL RLD 1997-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL RLD 1997-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL RLD 1997-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020579-001 FLOMAX 0.4MG CAPSULE / ORAL AB RLD, RS 1997-04-15 f41ea6bd6efb…
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 4 of 4 · 63 matching rows.
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5837 FLOMAX tamsulosin hydrochloride sanofi-aventis U.S. LLC NDA Current 0024-5837 FLOMAX tamsulosin hydrochloride sanofi-aventis U.S. LLC NDA Current 0024-5837 FLOMAX tamsulosin hydrochloride sanofi-aventis U.S. LLC NDA Current 0597-0058 Flomax tamsulosin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0058 Flomax tamsulosin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0058 Flomax tamsulosin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 63629-3384 Flomax tamsulosin hydrochloride Bryant Ranch Prepack NDA Current 63629-3384 Flomax tamsulosin hydrochloride Bryant Ranch Prepack NDA Current 67296-1803 FLOMAX tamsulosin hydrochloride RedPharm Drug, Inc. NDA Current 67296-1803 FLOMAX tamsulosin hydrochloride RedPharm Drug, Inc. NDA Current 70518-0518 Flomax tamsulosin hydrochloride REMEDYREPACK INC. NDA Current 70518-0518 Flomax tamsulosin hydrochloride REMEDYREPACK INC. NDA Current