Details for New Drug Application (NDA): 020225
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NDA 020225 describes IMDUR, which is a drug marketed by Schering Plough and is included in one NDA. Additional details are available on the IMDUR profile page.
The generic ingredient in IMDUR is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
The generic ingredient in IMDUR is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 020225
| Tradename: | IMDUR |
| Applicant: | Schering Plough |
| Ingredient: | isosorbide mononitrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 12, 1993 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 12, 1993 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 30, 1995 | TE: | RLD: | Yes | |||||
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