Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022527

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GILENYA (FINGOLIMOD HYDROCHLORIDE)
EQ 0.25MG BASE Marketing Status: Prescription

Active Ingredient: FINGOLIMOD HYDROCHLORIDE
Proprietary Name: GILENYA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022527
Product Number: 002
Approval Date: May 11, 2018
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

GILENYA (FINGOLIMOD HYDROCHLORIDE)
EQ 0.5MG BASE Marketing Status: Prescription

Active Ingredient: FINGOLIMOD HYDROCHLORIDE
Proprietary Name: GILENYA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022527
Product Number: 001
Approval Date: Sep 21, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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