Details for New Drug Application (NDA): 086031
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The generic ingredient in ISOSORBIDE DINITRATE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 086031
Tradename: | ISOSORBIDE DINITRATE |
Applicant: | Watson Labs Teva |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 086031
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 29, 1987 | TE: | RLD: | No |
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