FDA Orange Book · active-ingredient family
Cilostazol
Cilostazol is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PLETAL · NDA 020863
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PLETALRLD×2 | OTSUKA | NDA 020863 | — | Jan 15, 1999 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CILOSTAZOL×2 | CHARTWELL RX | ANDA 077831 | AB | Sep 24, 2012 | |
| CILOSTAZOL×2 | SANKALP LIFECARE | ANDA 077708 | — | Sep 28, 2009 | |
| CILOSTAZOL×2 | PLIVA HRVATSKA DOO | ANDA 077898 | — | Oct 29, 2007 | |
| CILOSTAZOL×2 | RISING | ANDA 077323 | — | Apr 20, 2006 | |
| CILOSTAZOL×2 | SLATE RUN PHARMA | ANDA 077208 | AB | Mar 29, 2006 | |
| CILOSTAZOL | CHARTWELL RX | ANDA 077310 | — | Nov 08, 2005 | |
| CILOSTAZOL×2 | HIKMA | ANDA 077024 | — | May 17, 2005 | |
| CILOSTAZOL×2 | EPIC PHARMA LLC | ANDA 077022 | AB | Mar 11, 2005 | |
| CILOSTAZOL | IVAX SUB TEVA PHARMS | ANDA 077020 | — | Mar 01, 2005 | |
| CILOSTAZOL×2 | APOTEX | ANDA 077030 | AB | Dec 10, 2004 | |
| CILOSTAZOL | ACTAVIS ELIZABETH | ANDA 077028 | — | Nov 26, 2004 | |
| CILOSTAZOL×2 | TEVA | ANDA 077027 | AB | Nov 24, 2004 | |
| CILOSTAZOL×2 | AUROBINDO PHARMA USA | ANDA 077019 | — | Nov 23, 2004 | |
| CILOSTAZOL | CHARTWELL RX | ANDA 077021 | — | Nov 23, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Cilostazol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
