Cilostazol

Reduces symptoms of intermittent claudication. ANDA 77310, held by Chartwell Rx. Cilostazol.

As of Nov 15, 2026, ANDA 77310 (Cilostazol), held by Chartwell Rx, was first approved by FDA on Nov 8, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2005
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 8, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cilostazol50MG · tablet;oral	Cilostazol	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 1, 2017	Supplement 12Manufacturing	Approved	None posted
Apr 4, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Mar 10, 2008	Supplement 3Labeling	Approved	None posted
Nov 8, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77310
Drugs@FDA: Overview at FDA
Company: Chartwell RX

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters