Home Applications 020695 Application 020695
Type NDA
Sponsor OTSUKA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RAXAR GREPAFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 200MG BASE No No 002 RAXAR GREPAFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE No No 003 RAXAR GREPAFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 600MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020695-001 RAXAR GREPAFLOXACIN HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 1997-11-06 N020695-002 RAXAR GREPAFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 1998-05-14 N020695-003 RAXAR GREPAFLOXACIN HYDROCHLORIDE EQ 600MG BASE TABLET / ORAL 1998-05-14
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.
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 2026-08-01 22:54:32 2026-06 N020695-001 RAXAR EQ 200MG BASE TABLET / ORAL 1997-11-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N020695-002 RAXAR EQ 400MG BASE TABLET / ORAL 1998-05-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N020695-003 RAXAR EQ 600MG BASE TABLET / ORAL 1998-05-14 a50c72e98297…
Documents# Document, Submission type, Date table Document Submission type Date 41560 ORIG 2004-07-15 41561 SUPPL 2004-06-28