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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019816


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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 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:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 24, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 8, 1995TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 8, 1995TE:RLD:Yes

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