FDA Orange Book · active-ingredient family
Dipyridamole
Dipyridamole: 2 brands, 22 generics; first approved Dec 22, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
22
Listed patents
0
Presentations
38
Brand (NDA) products
Originator applications
- BOEHRINGER INGELHEIMNDA 0198171990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - PERSANTINERLDBOEHRINGER INGELHEIMNDA 01283619863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- DIPYRIDAMOLECHARTWELL RXANDA 04089820083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — - DIPYRIDAMOLEZYDUS PHARMS USA INCANDA 04087420083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - DIPYRIDAMOLEIMPAX LABSANDA 04078220073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - DIPYRIDAMOLERISINGANDA 04073320073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - DIPYRIDAMOLEOXFORD PHARMSANDA 04054220063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - DIPYRIDAMOLEEUGIA PHARMA SPECLTSANDA 0757692002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DIPYRIDAMOLEFRESENIUS KABI USAANDA 0749561998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DIPYRIDAMOLERSCHARTWELL INJECTABLEANDA 0749391998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - DIPYRIDAMOLEHOSPIRAANDA 0746011997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DIPYRIDAMOLEDR REDDYSANDA 0749521997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - DIPYRIDAMOLEHIKMAANDA 0745211996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - DIPYRIDAMOLEWATSON LABSANDA 0871601996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DIPYRIDAMOLEANI PHARMSANDA 08694419913 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — - DIPYRIDAMOLEGLENMARK GENERICSANDA 0889991991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIPYRIDAMOLEGLENMARK GENERICSANDA 0890001991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DIPYRIDAMOLEGLENMARK GENERICSANDA 0890011991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - DIPYRIDAMOLEBARRANDA 0871841990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - DIPYRIDAMOLEBARRANDA 0877161990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - DIPYRIDAMOLEBARR LABSANDA 0877171990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB - DIPYRIDAMOLEPUREPAC PHARMANDA 0894251990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DIPYRIDAMOLEPUREPAC PHARMANDA 0894261990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DIPYRIDAMOLEPUREPAC PHARMANDA 0894271990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG 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
40 yr 3 mo ago
Most recent approval
18 yr 7 mo ago
Approvals span 1986–2008 across 24 FDA applications.
Brand (NDA) 28%
Generic (ANDA) 2292%
Dipyridamole: 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.
