Product Details for NDA 018754
ORUDIS (KETOPROFEN)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOPROFEN
Proprietary Name: ORUDIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018754
Product Number: 001
Approval Date: Jul 31, 1987
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
ORUDIS (KETOPROFEN)
Proprietary Name: ORUDIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018754
Product Number: 001
Approval Date: Jul 31, 1987
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOPROFEN
Proprietary Name: ORUDIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018754
Product Number: 002
Approval Date: Jan 9, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
ORUDIS (KETOPROFEN)
Proprietary Name: ORUDIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018754
Product Number: 002
Approval Date: Jan 9, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOPROFEN
Proprietary Name: ORUDIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG **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: N018754
Product Number: 003
Approval Date: Jan 9, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ORUDIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG **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: N018754
Product Number: 003
Approval Date: Jan 9, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information