Product Details for NDA 020584
LODINE XL (ETODOLAC)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETODOLAC
Proprietary Name: LODINE XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020584
Product Number: 001
Approval Date: Oct 25, 1996
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
LODINE XL (ETODOLAC)
Proprietary Name: LODINE XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020584
Product Number: 001
Approval Date: Oct 25, 1996
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETODOLAC
Proprietary Name: LODINE XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020584
Product Number: 003
Approval Date: Jan 20, 1998
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
LODINE XL (ETODOLAC)
Proprietary Name: LODINE XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020584
Product Number: 003
Approval Date: Jan 20, 1998
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETODOLAC
Proprietary Name: LODINE XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG **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: N020584
Product Number: 002
Approval Date: Oct 25, 1996
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LODINE XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG **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: N020584
Product Number: 002
Approval Date: Oct 25, 1996
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information