Details for New Drug Application (NDA): 019816
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The generic ingredient in ORUVAIL is ketoprofen. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.
Summary for 019816
Tradename: | ORUVAIL |
Applicant: | Wyeth Pharms Inc |
Ingredient: | ketoprofen |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019816
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 24, 1993 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 8, 1995 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 8, 1995 | TE: | RLD: | Yes |
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