← FDA DRUG APPROVALS

FDA ANDA · ANDA076593

CIPROFLOXACIN HYDROCHLORIDE

Sponsor: AIPING PHARM INC

APPLICATION
ANDA076593
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-16
LATEST ACTION
2017-10-31
ROUTE
ORAL, Oral
DOSAGE FORM
TABLET, Tablet
MARKETING STATUS
Prescription, None (Tentative Approval)

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
CIPROFLOXACINNone (Tentative Approval)
CIPROFLOXACIN 100MG · Tablet · Oral

Approval history

2017-10-31Labeling · Supplement 3 · standardAP
2017-10-31Labeling · Supplement 4 · standardAP
2004-03-16Original — Letter ↗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.

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 →