Home Applications 050686 Application 050686
Type NDA
Sponsor SI PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEDAX CEFTIBUTEN DIHYDRATE FOR SUSPENSION;ORAL EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 CEDAX CEFTIBUTEN DIHYDRATE FOR SUSPENSION;ORAL EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050686-001 CEDAX CEFTIBUTEN DIHYDRATE EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 N050686-002 CEDAX CEFTIBUTEN DIHYDRATE EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20
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 3 of 3 · 88 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UTC 2022-10 N050686-001 CEDAX EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050686-002 CEDAX EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050686-001 CEDAX EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050686-002 CEDAX EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050686-001 CEDAX EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050686-002 CEDAX EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050686-001 CEDAX EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050686-002 CEDAX EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 1995-12-20 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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59630-821 Cedax Ceftibuten dihydrate Sciele Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30277 SUPPL 2011-03-16 39113 SUPPL 2011-03-14 8004 SUPPL 2010-11-08 39112 SUPPL 2009-02-12 8003 SUPPL 2009-02-12