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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208014

FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD HYDROCHLORIDE)
EQ 0.5MG BASE
Marketing Status: Prescription
Active Ingredient: FINGOLIMOD HYDROCHLORIDE
Proprietary Name: FINGOLIMOD HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208014
Product Number: 001
Approval Date: Dec 4, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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