Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208854

SYMPROIC (NALDEMEDINE TOSYLATE)
EQ 0.2MG BASE Marketing Status: Prescription

Active Ingredient: NALDEMEDINE TOSYLATE
Proprietary Name: SYMPROIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208854
Product Number: 001
Approval Date: Mar 23, 2017
Applicant Holder Full Name: SHIONOGI INC
Marketing Status:  Prescription
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