Home Applications 020013 Application 020013
Type NDA
Sponsor PHARMACIA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MAXAQUIN LOMEFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020013-001 MAXAQUIN LOMEFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL 1992-02-21
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 · 43 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 2022-09-29 23:25 UTC 2022-09 N020013-001 MAXAQUIN EQ 400MG BASE TABLET / ORAL 1992-02-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020013-001 MAXAQUIN EQ 400MG BASE TABLET / ORAL 1992-02-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020013-001 MAXAQUIN EQ 400MG BASE TABLET / ORAL 1992-02-21 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 34183 SUPPL 2005-03-18 1911 SUPPL 2005-03-18 12140 SUPPL 2004-04-05 1910 SUPPL 2004-03-10 12139 SUPPL 2003-04-17