Details for New Drug Application (NDA): 019816
NDA 019816 describes ORUVAIL, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the ORUVAIL profile page.
The generic ingredient in ORUVAIL is ketoprofen. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.
The generic ingredient in ORUVAIL is ketoprofen. There is one drug master file entry 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CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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CAPSULE, EXTENDED RELEASE;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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