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PLETAL

NDA

CILOSTAZOL | N020863 | OTSUKA PHARMACEUTICAL CO LTD

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs6 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDCILOSTAZOL

DMF 166452003

TAPI NL BVCILOSTAZOL USP

DMF 167222003

ALIVUS LIFE SCIENCES LTDCILOSTAZOL USP

DMF 168762003

DIPHARMA FRANCIS SRLCILOSTAZOL

DMF 170502003

CHONGQING KANGLE PHARMACEUTICAL CO LTDCILOSTAZOL USP (DRUG SUBSTANCE, NON-STERILE)

DMF 224632009

CHONGQING KANGLE PHARMACEUTICAL CO LTDCILOSTAZOL USP

DMF 256662011

COHANCE LIFESCIENCES LTDCILOSTAZOL

DMF 431812025

SA AJINOMOTO OMNICHEM NVInactiveCILOSTAZOL

DMF 173722004

ALEMBIC PHARMACEUTICALS LTDInactiveCILOSTAZOL

DMF 174752004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveCILOSTAZOL

DMF 179732004

RANBAXY LABORATORIES LTDInactiveCILOSTAZOL DRUG SUBSTANCE

DMF 190762005

IPCA LABORATORIES LTDInactiveCILOSTAZOL USP

DMF 216782008

CHONGQING KANGLE PHARMACEUTICAL CO LTDInactiveCILOSTAZOL DRUG SUBSTANCE NON STERILE

DMF 226432008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
May 19, 2017	SUPPL -24	View Letter (PDF)
Jul 31, 2015	SUPPL -23	View Letter (PDF)
Jan 26, 2015	SUPPL -22	View Letter (PDF)
Nov 19, 2007	SUPPL -21	View Letter (PDF)
Jan 25, 2007	SUPPL -19	View Letter (PDF)
Nov 30, 2005	SUPPL -11	View Letter (PDF)
Mar 3, 2004	SUPPL -7	View Letter (PDF)
Jan 15, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 15, 1999

No patent or exclusivity listings for this strength.

#002 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 15, 1999