Home Applications 020920 Application 020920
Type NDA
Sponsor SCIOS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NATRECOR NESIRITIDE RECOMBINANT FOR SOLUTION;INTRAVENOUS 1.5MG/VIAL Yes 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date N020920-001 NATRECOR NESIRITIDE 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SOLUTION / INTRAVENOUS RLD 2001-08-10
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 2 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 2022-10-28 04:53 UTC 2022-10 N020920-001 NATRECOR 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SOLUTION / INTRAVENOUS RLD 2001-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020920-001 NATRECOR 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SOLUTION / INTRAVENOUS RLD 2001-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020920-001 NATRECOR 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SOLUTION / INTRAVENOUS RLD 2001-08-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020920-001 NATRECOR 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SOLUTION / INTRAVENOUS RLD 2001-08-10 a50c72e98297…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65847-205 NATRECOR NESIRITIDE Scios LLC NDA Current 65847-205 NATRECOR NESIRITIDE Scios LLC NDA Current 65847-205 NATRECOR NESIRITIDE Scios LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57331 SUPPL 2019-01-23 57168 SUPPL 2019-01-10 13745 SUPPL 2013-04-30 3758 SUPPL 2013-04-30 13744 SUPPL 2012-07-10 3757 SUPPL 2012-07-09 13743 SUPPL 2009-06-22 3756 SUPPL 2009-06-17 13742 SUPPL 2007-04-16 3755 SUPPL 2006-12-28 26205 SUPPL 2005-05-02 35650 SUPPL 2005-04-28 3754 SUPPL 2005-04-28 26204 SUPPL 2004-07-06 41813 ORIG 2001-08-10 35649 ORIG 2001-08-10 3753 ORIG 2001-08-10