Cilostazol

ANDA 77722, held by Chartwell Rx. Cilostazol.

As of Nov 15, 2026, ANDA 77722 (Cilostazol), held by Chartwell Rx, was first approved by FDA on Sep 24, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 24, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 24, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cilostazol50MG · tablet;oral	Cilostazol	Rx

All 2 submissions, including labeling and manufacturing supplements


Mar 29, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Sep 24, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 77722
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