Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022511

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VIMOVO (ESOMEPRAZOLE MAGNESIUM; NAPROXEN)
EQ 20MG BASE;375MG Marketing Status: Prescription

Active Ingredient: ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Proprietary Name: VIMOVO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE;375MG
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:  Prescription
Patent and Exclusivity Information

VIMOVO (ESOMEPRAZOLE MAGNESIUM; NAPROXEN)
EQ 20MG BASE;500MG Marketing Status: Prescription

Active Ingredient: ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Proprietary Name: VIMOVO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE;500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022511
Product Number: 001
Approval Date: Apr 30, 2010
Applicant Holder Full Name: HORIZON MEDICINES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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