FDA Orange Book · active-ingredient family
Isosorbide mononitrate
Isosorbide mononitrate: 3 brands, 20 generics; first approved Dec 30, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
20
Listed patents
0
Presentations
50
Brand (NDA) products
Originator applications
- IMDURRLDSCHERING PLOUGHNDA 02022519933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - 120MG TABLET, EXTENDED RELEASE ORAL Discontinued - - MONOKETRLDOMNIVIUM PHARMSNDA 02021519932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - PROMIUS PHARMANDA 0190911991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued -
Generic (ANDA) products (20)
Abbreviated applications
- ISOSORBIDE MONONITRATEANI PHARMSANDA 07514720262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - ISOSORBIDE MONONITRATEZYDUS PHARMSANDA 21825520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - 120MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATESHANDONGANDA 21411520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG TABLET, EXTENDED RELEASE ORAL Rx AB 30MG TABLET, EXTENDED RELEASE ORAL Rx AB 60MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATEAUROBINDO PHARMAANDA 21655720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Rx AB 60MG TABLET, EXTENDED RELEASE ORAL Rx AB 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATERICONPHARMA LLCANDA 21091820183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Rx AB 60MG TABLET, EXTENDED RELEASE ORAL Rx AB 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATEDEXCEL LTDANDA 2108222018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATEACCORD HLTHCAREANDA 20968420173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - 120MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATEDEXCEL LTDANDA 07552220162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Rx AB 30MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATETORRENT PHARMSANDA 2002702011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATETORRENT PHARMSANDA 20049520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Rx AB 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATESTRIDES PHARMA INTLANDA 09059820103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - 120MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATEHIKMA INTL PHARMSANDA 07681320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATEIVAX SUB TEVA PHARMSANDA 07544820013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - 120MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATEHIKMA PHARMSANDA 0753612000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - ISOSORBIDE MONONITRATEZYDUS HLTHCAREANDA 07539520003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Rx AB 60MG TABLET, EXTENDED RELEASE ORAL Rx AB 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATECHARTWELL MOLECULARANDA 07515520003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Rx AB 30MG TABLET, EXTENDED RELEASE ORAL Rx AB 120MG TABLET, EXTENDED RELEASE ORAL Rx AB - ISOSORBIDE MONONITRATESKYEPHARMA AGANDA 0751661999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATEACTAVIS ELIZABETHANDA 07530619982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE ORAL Discontinued - 60MG TABLET, EXTENDED RELEASE ORAL Discontinued - - ISOSORBIDE MONONITRATEGENUSANDA 07503719982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - ISOSORBIDE MONONITRATEALKERMES GAINESVILLEANDA 0750411998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET, EXTENDED RELEASE 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
35 yr 4 mo ago
Most recent approval
7 mo ago
Approvals span 1991–2026 across 23 FDA applications.
Brand (NDA) 313%
Generic (ANDA) 2087%
Isosorbide mononitrate: 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.
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