← FDA DRUG APPROVALS

FDA ANDA · ANDA076126

CIPROFLOXACIN

ciprofloxacin hydrochloride

Sponsor: CARLSBAD

APPLICATION
ANDA076126
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-09
LATEST ACTION
2015-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
CIPROFLOXACINPrescription
CIPROFLOXACIN 250MG · TABLET · ORAL

Approval history

2015-12-01Labeling · Supplement 12 · standardAP
2015-12-01Labeling · Supplement 11 · standardAP
2012-12-17Labeling · Supplement 10 · standardAP
2012-05-24Labeling · Supplement 9 · standardAP
2011-05-16Labeling · Supplement 8AP
2009-09-28Labeling · Supplement 6AP
2009-03-20Labeling · Supplement 5AP
2004-06-09OriginalLetterAP
2004-06-09Not Applicable · Supplement 15LetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →