FDA Orange Book · active-ingredient family
Isosorbide dinitrate
Isosorbide dinitrate: 7 brands, 34 generics; first approved Sep 18, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 34 ANDA applications approved.
Brands (NDA)
7
Generics (ANDA)
34
Listed patents
0
Presentations
62
Brand (NDA) products
Originator applications
- DILATRATE-SRRLDENDO OPERATIONSNDA 0197901988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG CAPSULE, EXTENDED RELEASE ORAL Discontinued - - ISORDILRLDBAUSCHNDA 01209319885 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 10MG TABLET ORAL Discontinued - 30MG TABLET ORAL Discontinued - 20MG TABLET ORAL Discontinued - 5MG TABLET ORAL Rx AB - ISORDILRLDBIOVAILNDA 01294019883 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET SUBLINGUAL Discontinued - 2.5MG TABLET SUBLINGUAL Discontinued - 10MG TABLET SUBLINGUAL Discontinued - - ASTRAZENECANDA 01677619962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL Discontinued - 10MG TABLET, CHEWABLE ORAL Discontinued - - ASTRAZENECANDA 01619219962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - ASTRAZENECANDA 01619119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET SUBLINGUAL Discontinued - 2.5MG TABLET SUBLINGUAL Discontinued - - WYETH AYERSTNDA 01288219882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, EXTENDED RELEASE ORAL Discontinued - 40MG CAPSULE, EXTENDED RELEASE ORAL Discontinued -
Generic (ANDA) products (34)
Abbreviated applications
- ISOSORBIDE DINITRATERUBICON RESEARCHANDA 21572320225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEPH HEALTHANDA 2112902021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEZYDUS LIFESCIENCESANDA 21305720195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEIMPAX LABS INCANDA 0407232008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE DINITRATEHIKMA INTL PHARMSANDA 0405912007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDS INCANDA 0400091998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ASTRAZENECAANDA 0864051990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - ASTRAZENECAANDA 0881241990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued - - ASTRAZENECAANDA 0881251990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESANDOZANDA 0893671988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEWATSON LABSANDA 0860331988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATESANDOZANDA 0862251988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATESANDOZANDA 0862221988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATERSPH HEALTHANDA 0879461988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEANI PHARMSANDA 0860321988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESANDOZANDA 0862211988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATESANDOZANDA 0862231988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEWATSON LABSANDA 0860341988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATEHIKMA INTL PHARMSANDA 08808819873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEHIKMA INTL PHARMSANDA 08605519872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET SUBLINGUAL Discontinued - 2.5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATEPH HEALTHANDA 0875371987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEWATSON LABS TEVAANDA 0860311987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATEPH HEALTHANDA 0869231987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATEPH HEALTHANDA 0869251987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - ISOSORBIDE DINITRATESUPERPHARMANDA 0891901987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUPERPHARMANDA 0891911987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUPERPHARMANDA 0891921987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0861661986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0861691986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0861671986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0875641986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0842041986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0861681986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET SUBLINGUAL Discontinued - - ISOSORBIDE DINITRATESUN PHARM INDUSTRIESANDA 0875451986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET SUBLINGUAL 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 8 mo ago
Most recent approval
4 yr 4 mo ago
Approvals span 1986–2022 across 41 FDA applications.
Brand (NDA) 717%
Generic (ANDA) 3483%
Isosorbide dinitrate: 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.
Assyro Intelligence
Ask anything about Isosorbide dinitrate
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo