FDA Orange Book · active-ingredient family
Cilostazol
Cilostazol: 1 brand, 14 generics; first approved Jan 15, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
14
Listed patents
0
Presentations
26
Brand (NDA) products
Originator applications
- PLETALRLDOTSUKANDA 02086319992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- CILOSTAZOLCHARTWELL RXANDA 07783120122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CILOSTAZOLSANKALP LIFECAREANDA 07770820092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CILOSTAZOLPLIVA HRVATSKA DOOANDA 07789820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CILOSTAZOLRISINGANDA 07732320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - CILOSTAZOLSLATE RUN PHARMAANDA 07720820062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CILOSTAZOLCHARTWELL RXANDA 0773102005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CILOSTAZOLHIKMAANDA 07702420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CILOSTAZOLEPIC PHARMA LLCANDA 07702220052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CILOSTAZOLIVAX SUB TEVA PHARMSANDA 0770202005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CILOSTAZOLAPOTEXANDA 07703020042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CILOSTAZOLACTAVIS ELIZABETHANDA 0770282004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CILOSTAZOLRSTEVAANDA 07702720042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CILOSTAZOLAUROBINDO PHARMA USAANDA 07701920042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CILOSTAZOLCHARTWELL RXANDA 0770212004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
28 yr ago
Most recent approval
14 yr 1 mo ago
Approvals span 1999–2012 across 15 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1493%
Cilostazol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
