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Product Details for NDA 208399

VARUBI (ROLAPITANT HYDROCHLORIDE)
EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) Marketing Status: Prescription

Active Ingredient: ROLAPITANT HYDROCHLORIDE
Proprietary Name: VARUBI
Dosage Form; Route of Administration: EMULSION; IV (INFUSION)
Strength: EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208399
Product Number: 001
Approval Date: Oct 25, 2017
Applicant Holder Full Name: TESARO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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