Home Applications 018569 Application 018569
Type NDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG No No 002 FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG No No 005 FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018569-001 FUROSEMIDE FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 N018569-002 FUROSEMIDE FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 N018569-005 FUROSEMIDE FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018569-002 FUROSEMIDE 20MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018569-005 FUROSEMIDE 80MG TABLET / ORAL AB 1984-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018569-001 FUROSEMIDE 40MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 1 · 2 matching rows.
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 0615-1571 Furosemide Furosemide NCS HealthCare of KY, Inc dba Vangard Labs NDA Current 0781-1446 Furosemide Furosemide Sandoz Inc NDA Current 0781-1446 Furosemide Furosemide Sandoz Inc NDA Current 0781-1818 Furosemide Furosemide Sandoz Inc NDA Current 0781-1818 Furosemide Furosemide Sandoz Inc NDA Current 0781-1966 Furosemide Furosemide Sandoz Inc NDA Current 0781-1966 Furosemide Furosemide Sandoz Inc NDA Current 43353-737 Furosemide Furosemide Aphena Pharma Solutions - Tennessee, LLC NDA Current 48433-314 Furosemide Furosemide Safecor Health, LLC NDA Current 49999-030 Furosemide Furosemide Lake Erie Medical DBA Quality Care Products LLC NDA Current 50090-0150 Furosemide Furosemide A-S Medication Solutions NDA Current 50090-0154 Furosemide Furosemide A-S Medication Solutions NDA Current 55154-5875 Furosemide Furosemide Cardinal Health NDA Current 67046-222 Furosemide Furosemide Contract Pharmacy Services-PA NDA Current 67544-075 Furosemide Furosemide Aphena Pharma Solutions - Tennessee, LLC NDA Current 68071-3144 Furosemide Furosemide NuCare Pharmaceuticals, Inc. NDA Current 68071-4015 Furosemide Furosemide NuCare Pharmaceuticals,Inc. NDA Current 70518-0584 Furosemide Furosemide REMEDYREPACK INC. NDA Current 70518-0584 Furosemide Furosemide REMEDYREPACK INC. NDA Current 70518-0745 Furosemide Furosemide REMEDYREPACK INC. NDA Current 70518-0745 Furosemide Furosemide REMEDYREPACK INC. NDA Current 70859-020 Furosemide Furosemide NuCare Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65748 SUPPL 2020-12-28 65698 SUPPL 2020-12-23 45529 SUPPL 2016-10-12