FDA Orange Book · active-ingredient family
Isradipine
Isradipine is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DYNACIRC CR · NDA 020336
2
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DYNACIRC CRRLD×2 | GLAXOSMITHKLINE LLC | NDA 020336 | — | Jun 01, 1994 | |
| DYNACIRCRLD×2 | SMITHKLINE BEECHAM | NDA 019546 | — | Dec 20, 1990 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISRADIPINE×2 | PHARMOBEDIENT | ANDA 201067 | — | Nov 27, 2015 | |
| ISRADIPINE×2 | ELITE LABS INC | ANDA 077169 | AB | Apr 24, 2006 | |
| ISRADIPINE×2 | WATSON LABS TEVA | ANDA 077317 | AB | Jan 05, 2006 |
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.
Isradipine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
