Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204760

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MOVANTIK (NALOXEGOL OXALATE)
EQ 12.5MG BASE
Marketing Status: Prescription

Active Ingredient: NALOXEGOL OXALATE
Proprietary Name: MOVANTIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204760
Product Number: 001
Approval Date: Sep 16, 2014
Applicant Holder Full Name: VALINOR PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MOVANTIK (NALOXEGOL OXALATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: NALOXEGOL OXALATE
Proprietary Name: MOVANTIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204760
Product Number: 002
Approval Date: Sep 16, 2014
Applicant Holder Full Name: VALINOR PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information