FDA Orange Book · active-ingredient family
Isosorbide dinitrate
Isosorbide dinitrate is approved as 7 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DILATRATE-SR · NDA 019790
7
Brand (NDA)
34
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet, tablet, chewable, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DILATRATE-SRRLD | ENDO OPERATIONS | NDA 019790 | — | Sep 02, 1988 | |
| ISORDILRLD×5 | BAUSCH | NDA 012093 | AB | Jul 29, 1988 | |
| ISORDILRLD×3 | BIOVAIL | NDA 012940 | — | Jul 29, 1988 | |
| SORBITRATE×2 | ASTRAZENECA | NDA 016776 | — | Apr 01, 1996 | |
| SORBITRATE×2 | ASTRAZENECA | NDA 016192 | — | Apr 01, 1996 | |
| SORBITRATE×2 | ASTRAZENECA | NDA 016191 | — | Apr 01, 1996 | |
| ISORDIL×2 | WYETH AYERST | NDA 012882 | — | Jul 29, 1988 |
Generic (ANDA) products (34)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE×5 | RUBICON RESEARCH | ANDA 215723 | AB | Jul 08, 2022 | |
| ISOSORBIDE DINITRATE | PH HEALTH | ANDA 211290 | AB | Nov 23, 2021 | |
| ISOSORBIDE DINITRATE×5 | ZYDUS LIFESCIENCES | ANDA 213057 | AB | Nov 20, 2019 | |
| ISOSORBIDE DINITRATE | IMPAX LABS INC | ANDA 040723 | — | Mar 17, 2008 | |
| ISOSORBIDE DINITRATE | HIKMA INTL PHARMS | ANDA 040591 | — | Jan 10, 2007 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDS INC | ANDA 040009 | — | Dec 30, 1998 | |
| SORBITRATE | ASTRAZENECA | ANDA 086405 | — | Aug 21, 1990 | |
| SORBITRATE | ASTRAZENECA | ANDA 088124 | — | Aug 21, 1990 | |
| SORBITRATE | ASTRAZENECA | ANDA 088125 | — | Aug 21, 1990 | |
| ISOSORBIDE DINITRATE | SANDOZ | ANDA 089367 | AB | Apr 07, 1988 | |
| ISOSORBIDE DINITRATE | WATSON LABS | ANDA 086033 | — | Feb 26, 1988 | |
| ISOSORBIDE DINITRATE | SANDOZ | ANDA 086225 | — | Feb 19, 1988 | |
| ISOSORBIDE DINITRATE | SANDOZ | ANDA 086222 | — | Feb 19, 1988 | |
| ISOSORBIDE DINITRATE | PH HEALTH | ANDA 087946 | AB | Jan 12, 1988 | |
| ISOSORBIDE DINITRATE | ANI PHARMS | ANDA 086032 | — | Jan 07, 1988 | |
| ISOSORBIDE DINITRATE | SANDOZ | ANDA 086221 | AB | Jan 07, 1988 | |
| ISOSORBIDE DINITRATE | SANDOZ | ANDA 086223 | AB | Jan 07, 1988 | |
| ISOSORBIDE DINITRATE | WATSON LABS | ANDA 086034 | — | Jan 06, 1988 | |
| ISOSORBIDE DINITRATE×3 | HIKMA INTL PHARMS | ANDA 088088 | AB | Oct 29, 1987 | |
| ISOSORBIDE DINITRATE×2 | HIKMA INTL PHARMS | ANDA 086055 | — | Oct 29, 1987 | |
| ISOSORBIDE DINITRATE | PH HEALTH | ANDA 087537 | AB | Oct 02, 1987 | |
| ISOSORBIDE DINITRATE | WATSON LABS TEVA | ANDA 086031 | — | Sep 29, 1987 | |
| ISOSORBIDE DINITRATE | PH HEALTH | ANDA 086923 | AB | Mar 12, 1987 | |
| ISOSORBIDE DINITRATE | PH HEALTH | ANDA 086925 | AB | Mar 12, 1987 | |
| ISOSORBIDE DINITRATE | SUPERPHARM | ANDA 089190 | — | Feb 17, 1987 | |
| ISOSORBIDE DINITRATE | SUPERPHARM | ANDA 089191 | — | Feb 17, 1987 | |
| ISOSORBIDE DINITRATE | SUPERPHARM | ANDA 089192 | — | Feb 17, 1987 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 086166 | — | Sep 19, 1986 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 086169 | — | Sep 19, 1986 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 086167 | — | Sep 19, 1986 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 087564 | — | Sep 18, 1986 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 084204 | — | Sep 18, 1986 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 086168 | — | Sep 18, 1986 | |
| ISOSORBIDE DINITRATE | SUN PHARM INDUSTRIES | ANDA 087545 | — | Sep 18, 1986 |
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.
Isosorbide dinitrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
