Details for New Drug Application (NDA): 040723
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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 040723
Tradename: | ISOSORBIDE DINITRATE |
Applicant: | Impax Labs Inc |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 040723
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 40MG | ||||
Approval Date: | Mar 17, 2008 | TE: | RLD: | No |
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