Details for New Drug Application (NDA): 012940
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The generic ingredient in ISORDIL is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 012940
Tradename: | ISORDIL |
Applicant: | Biovail |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 012940
Profile for product number 003
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| Dosage: | TABLET;SUBLINGUAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Jul 29, 1988 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 29, 1988 | TE: | RLD: | Yes |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 29, 1988 | TE: | RLD: | Yes |
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