Home Applications 016273 Application 016273
Type NDA
Sponsor US PHARM HOLDINGS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LASIX FUROSEMIDE TABLET;ORAL 40MG Yes No 002 LASIX FUROSEMIDE TABLET;ORAL 20MG Yes No 003 LASIX FUROSEMIDE TABLET;ORAL 80MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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Approval date N016273-001 LASIX FUROSEMIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N016273-002 LASIX FUROSEMIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N016273-003 LASIX FUROSEMIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982
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 4 of 4 · 132 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 2022-10-28 04:53 UTC 2022-10 N016273-001 LASIX 40MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N016273-002 LASIX 20MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N016273-003 LASIX 80MG TABLET / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N016273-001 LASIX 40MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N016273-002 LASIX 20MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N016273-003 LASIX 80MG TABLET / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016273-001 LASIX 40MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016273-002 LASIX 20MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016273-003 LASIX 80MG TABLET / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016273-001 LASIX 40MG TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016273-002 LASIX 20MG TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016273-003 LASIX 80MG TABLET / ORAL RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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 · 1 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 30698-060 Lasix FUROSEMIDE Validus Pharmaceuticals L NDA Current 30698-060 Lasix FUROSEMIDE Validus Pharmaceuticals LLC NDA Current 30698-060 Lasix FUROSEMIDE Validus Pharmaceuticals LLC NDA Current 30698-066 Lasix FUROSEMIDE Validus Pharmaceuticals L NDA Current 30698-066 Lasix FUROSEMIDE Validus Pharmaceuticals LLC NDA Current 30698-066 Lasix FUROSEMIDE Validus Pharmaceuticals LLC NDA Current 30698-067 Lasix FUROSEMIDE Validus Pharmaceuticals L NDA Current 30698-067 Lasix FUROSEMIDE Validus Pharmaceuticals LLC NDA Current 30698-067 Lasix FUROSEMIDE Validus Pharmaceuticals LLC NDA Current 70518-2030 Lasix FUROSEMIDE REMEDYREPACK INC. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 62207 SUPPL 2020-03-19 55158 SUPPL 2018-08-10 12983 SUPPL 2016-03-08 10877 SUPPL 2016-03-08 33152 SUPPL 2012-03-28 428 SUPPL 2012-03-28 12982 SUPPL 2010-10-20 33151 SUPPL 2010-10-18 12981 SUPPL 2008-10-23 427 SUPPL 2006-02-22