Home Applications 050685 Application 050685
Type NDA
Sponsor SI PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 CEDAX CEFTIBUTEN DIHYDRATE CAPSULE;ORAL EQ 400MG BASE 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 N050685-002 CEDAX CEFTIBUTEN DIHYDRATE EQ 400MG BASE CAPSULE / ORAL 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 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 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 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 59630-820 Cedax Ceftibuten dihydrate Sciele Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30276 SUPPL 2010-11-08 30275 SUPPL 2009-02-12 18019 SUPPL 2009-02-12 57461 ORIG 1995-12-20