FDA Orange Book · active-ingredient family
Isradipine
Isradipine: 2 brands, 3 generics; first approved Dec 20, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
3
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- DYNACIRC CRRLDGLAXOSMITHKLINE LLCNDA 02033619942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - DYNACIRCRLDSMITHKLINE BEECHAMNDA 01954619902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Discontinued — 5MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- ISRADIPINEPHARMOBEDIENTANDA 20106720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ISRADIPINEELITE LABS INCANDA 07716920062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB - ISRADIPINEWATSON LABS TEVAANDA 07731720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB
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
36 yr 4 mo ago
Most recent approval
11 yr ago
Approvals span 1990–2015 across 5 FDA applications.
Brand (NDA) 240%
Generic (ANDA) 360%
Isradipine: 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.
