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FDA NDA · NDA020695

RAXAR

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APPLICATION
NDA020695
TYPE
NDA
ORIGINAL APPROVAL
1997-11-06
LATEST ACTION
1999-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RAXARDiscontinued
GREPAFLOXACIN HYDROCHLORIDE EQ 400MG BASE · TABLET · ORAL
RAXARDiscontinued
GREPAFLOXACIN HYDROCHLORIDE EQ 600MG BASE · TABLET · ORAL
RAXARDiscontinued
GREPAFLOXACIN HYDROCHLORIDE EQ 200MG BASE · TABLET · ORAL

Approval history

1999-09-15Labeling · Supplement 5 · standardAP
1998-09-23Labeling · Supplement 3 · standard — Review ↗AP
1998-08-17Manufacturing (CMC) · Supplement 2 · standardAP
1998-05-14Manufacturing (CMC) · Supplement 1 · standardAP
1997-11-06Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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