Reduces symptoms of intermittent claudication. ANDA 77021, held by Chartwell Rx. Cilostazol.
As of Nov 15, 2026, ANDA 77021 (Cilostazol), held by Chartwell Rx, was first approved by FDA on Nov 23, 2004, with 3 approved supplements and 0 published complete response letters.
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cilostazol100MG · tablet;oral | Cilostazol | Discontinued |
| Dec 1, 2017 | Supplement 14Manufacturing | Approved | None posted |
| Apr 4, 2016 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 10, 2008 | Supplement 4Labeling | Approved | None posted |
| Nov 23, 2004 | Original application | Approved |
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
