Details for New Drug Application (NDA): 019977
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NDA 019977 describes ORAMORPH SR, which is a drug marketed by Xanodyne Pharms Inc and is included in one NDA. Additional details are available on the ORAMORPH SR profile page.
The generic ingredient in ORAMORPH SR is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
The generic ingredient in ORAMORPH SR is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 019977
| Tradename: | ORAMORPH SR |
| Applicant: | Xanodyne Pharms Inc |
| Ingredient: | morphine sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019977
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 15, 1991 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Aug 15, 1991 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 15, 1991 | TE: | RLD: | No | |||||
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