Product Details for NDA 019816
ORUVAIL (KETOPROFEN)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOPROFEN
Proprietary Name: ORUVAIL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019816
Product Number: 003
Approval Date: Feb 8, 1995
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ORUVAIL (KETOPROFEN)
Proprietary Name: ORUVAIL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019816
Product Number: 003
Approval Date: Feb 8, 1995
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOPROFEN
Proprietary Name: ORUVAIL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019816
Product Number: 002
Approval Date: Feb 8, 1995
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ORUVAIL (KETOPROFEN)
Proprietary Name: ORUVAIL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019816
Product Number: 002
Approval Date: Feb 8, 1995
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOPROFEN
Proprietary Name: ORUVAIL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019816
Product Number: 001
Approval Date: Sep 24, 1993
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ORUVAIL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019816
Product Number: 001
Approval Date: Sep 24, 1993
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information