Cilostazol

As of Nov 15, 2026, ANDA 77323 (Cilostazol), held by Rising, was first approved by FDA on Apr 20, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 20, 2006
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 20, 2006	Original application	Approved	None posted

Products

2 strengths and forms


Cilostazol100MG · tablet;oral	Cilostazol	Discontinued
Cilostazol50MG · tablet;oral	Cilostazol	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Dec 28, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Dec 28, 2017	Supplement 8Labeling · Standard review	Approved	None posted
May 10, 2011	Supplement 6Labeling	Approved	None posted
Aug 31, 2010	Supplement 5Labeling	Approved	None posted
Apr 20, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77323
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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