Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206940

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VIBERZI (ELUXADOLINE)
75MG Marketing Status: Prescription

Active Ingredient: ELUXADOLINE
Proprietary Name: VIBERZI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206940
Product Number: 001
Approval Date: May 27, 2015
Applicant Holder Full Name: ALLERGAN HOLDINGS UNLTD CO
Marketing Status:  Prescription
Patent and Exclusivity Information

VIBERZI (ELUXADOLINE)
100MG Marketing Status: Prescription

Active Ingredient: ELUXADOLINE
Proprietary Name: VIBERZI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206940
Product Number: 002
Approval Date: May 27, 2015
Applicant Holder Full Name: ALLERGAN HOLDINGS UNLTD CO
Marketing Status:  Prescription
Patent and Exclusivity Information

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