← FDA DRUG APPROVALS

FDA ANDA · ANDA077021

CILOSTAZOL

Sponsor: CHARTWELL RX

APPLICATION
ANDA077021
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-23
LATEST ACTION
2017-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CILOSTAZOLDiscontinued
CILOSTAZOL 100MG · TABLET · ORAL

Approval history

2017-12-01Manufacturing (CMC) · Supplement 14AP
2016-04-04Labeling · Supplement 13 · standardAP
2008-03-10Labeling · Supplement 4AP
2004-11-23OriginalLetterAP
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 →