FDA.reportPublic FDA data

Application 019091

Type
NDA
Sponsor
PROMIUS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISMOISOSORBIDE MONONITRATETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019091-001ISMOISOSORBIDE MONONITRATE20MGTABLET / ORAL1991-12-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019091-001ISMO20MGTABLET / ORAL1991-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019091-001ISMO20MGTABLET / ORAL1991-12-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019091-001ISMO20MGTABLET / ORAL1991-12-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019091-001ISMO20MGTABLET / ORAL1991-12-30a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEREMEDYREPACK INC.d01d4f0f-5164-4ea3-b772-72b97961c6fb2026-07-31Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATECoupler LLC55f240e1-3056-38cc-e063-6294a90a814e2026-07-06Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECardinal Health 107, LLC72b8a20c-5833-4765-a4b5-9066eaec6ea12026-06-26Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEMajor Pharmaceuticals8cbb364a-bafe-454b-a53f-bd7cd69a55932026-05-27Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals Limited0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c2026-05-11Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEGenus Lifesciences Inc.0d739bf3-0672-4504-9064-b39d6b200b472026-04-09Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEANI Pharmaceuticals, Inc.06839534-85b8-42aa-b0e3-079ed236be442026-03-27Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEShandong New Time Pharmaceutical Co., Ltd.cd953cfa-b6f5-4b82-afcc-52a57236b9d32026-01-06Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATENorthwind Health Company, LLCdf5fd5e2-3a7b-5a5b-e053-2995a90a0dd32026-01-01Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATECoupler LLC46b3030d-f492-da9d-e063-6294a90a31b32025-12-24Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEChartwell RX, LLCb38f43c8-d02d-4aee-ab23-e898cbfadfbc2025-12-02Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrateISOSORBIDE MONONITRATECoupler LLC3e0e013f-6887-fa72-e063-6294a90a18ca2025-09-05Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrateISOSORBIDE MONONITRATECoupler LLC3dffc84e-93e4-0005-e063-6294a90aa9ca2025-09-04Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEBryant Ranch Prepackcd60ded0-01d9-4a51-a8ad-cdfeb27d88fb2025-08-26Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrateISOSORBIDE MONONITRATEOMNIVIUM PHARMACEUTICALS LLC.cdf01e14-778b-4b3f-8372-1c18f266fb982025-08-06Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEEdenbridge Pharmaceuticals LLC.7443a5b6-6153-4227-870c-3c710f1f21742025-06-06Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEEdenbridge Pharmaceuticals LLC.0e3c4461-2e04-481f-a9e5-29f21cc71ec52025-06-06Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECoupler LLC2d99893a-296a-134c-e063-6294a90ace3b2025-02-07Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEA-S Medication Solutions5fd86c08-18de-43a2-9962-ab6cbf57d6c02025-01-17Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE
Isosorbide MononitrateISOSORBIDE MONONITRATEGolden State Medical Supply, Inc.86be0e85-5337-bee4-e053-2a91aa0a81582024-11-11Warnings, Adverse reactionsName fallback
generic name: ISOSORBIDE MONONITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.