← FDA DRUG APPROVALS

FDA ANDA · ANDA076912

CIPROFLOXACIN HYDROCHLORIDE

Sponsor: TARO

APPLICATION
ANDA076912
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-06
LATEST ACTION
2012-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL

Approval history

2012-06-01Labeling · Supplement 6AP
2011-05-18Labeling · Supplement 5AP
2009-07-23Labeling · Supplement 4AP
2009-01-29Labeling · Supplement 3AP
2005-02-18Labeling · Supplement 1AP
2004-10-06OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →