Home Applications 021378 Application 021378
Type NDA
Sponsor FOREST LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COMBUNOX IBUPROFEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No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 N021378-001 COMBUNOX IBUPROFEN; OXYCODONE HYDROCHLORIDE 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-26
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UTC 2022-10 N021378-001 COMBUNOX 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021378-001 COMBUNOX 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021378-001 COMBUNOX 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021378-001 COMBUNOX 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-26 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 36799 SUPPL 2010-09-07 23258 ORIG 2009-11-16 27640 SUPPL 2007-07-05 15341 SUPPL 2007-06-27 5226 SUPPL 2006-03-23 36798 SUPPL 2006-03-10 21628 ORIG 2005-11-30 36797 ORIG 2004-12-02 5225 ORIG 2004-12-02