Application Nr Approved Date Route Status External Links
ANDA075037 1998-10-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Isosorbide Mononitrate Tablets, Usp Are Indicated For The Prevention And Treatment Of Angina Pectoris Due To Coronary Artery Disease. The Onset Of Action Of Oral Isosorbide Mononitrate Is Not Sufficiently Rapid For This Product To Be Useful In Aborting An Acute Anginal Episode.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Starch, Corn STARCH, CORN Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Isosorbide Mononitrate

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