Product Details for NDA 022511
VIMOVO (ESOMEPRAZOLE MAGNESIUM; NAPROXEN)
EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Proprietary Name: VIMOVO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022511
Product Number: 002
Approval Date: Apr 30, 2010
Applicant Holder Full Name: HORIZON MEDICINES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
VIMOVO (ESOMEPRAZOLE MAGNESIUM; NAPROXEN)
Proprietary Name: VIMOVO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022511
Product Number: 002
Approval Date: Apr 30, 2010
Applicant Holder Full Name: HORIZON MEDICINES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Proprietary Name: VIMOVO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022511
Product Number: 001
Approval Date: Apr 30, 2010
Applicant Holder Full Name: HORIZON MEDICINES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: VIMOVO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE;500MG **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: N022511
Product Number: 001
Approval Date: Apr 30, 2010
Applicant Holder Full Name: HORIZON MEDICINES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information