Orange Book product · Brand (NDA)
PLETAL
CILOSTAZOL
At a glance
Jan 15, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 15, 1999
27 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CILOSTAZOL
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020863
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2012CILOSTAZOLGeneric (ANDA)
ANDA 077831 · CHARTWELL RX
- 2009CILOSTAZOLGeneric (ANDA)
ANDA 077708 · SANKALP LIFECARE
- 2007CILOSTAZOLGeneric (ANDA)
ANDA 077898 · PLIVA HRVATSKA DOO
- 2006CILOSTAZOLGeneric (ANDA)
ANDA 077323 · RISING
- 2006CILOSTAZOLGeneric (ANDA)
ANDA 077208 · SLATE RUN PHARMA
- 2005CILOSTAZOLGeneric (ANDA)
ANDA 077310 · CHARTWELL RX
- 2005CILOSTAZOLGeneric (ANDA)
ANDA 077024 · HIKMA
- 2005CILOSTAZOLGeneric (ANDA)
ANDA 077022 · EPIC PHARMA LLC
- 2005CILOSTAZOLGeneric (ANDA)
ANDA 077020 · IVAX SUB TEVA PHARMS
- 2004CILOSTAZOLGeneric (ANDA)
ANDA 077030 · APOTEX
- 2004CILOSTAZOLGeneric (ANDA)
ANDA 077028 · ACTAVIS ELIZABETH
- 2004CILOSTAZOLGeneric (ANDA)
ANDA 077027 · TEVA
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.
