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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202521

PALONOSETRON HYDROCHLORIDE (PALONOSETRON HYDROCHLORIDE)
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: PALONOSETRON HYDROCHLORIDE
Proprietary Name: PALONOSETRON HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202521
Product Number: 001
Approval Date: Oct 13, 2015
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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