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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 208005

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NDA 208005 describes FINGOLIMOD HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in eighteen NDAs. It is available from seventeen suppliers. Additional details are available on the FINGOLIMOD HYDROCHLORIDE profile page.

The generic ingredient in FINGOLIMOD HYDROCHLORIDE is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

Summary for 208005

Tradename:	FINGOLIMOD HYDROCHLORIDE
Applicant:	Mylan
Ingredient:	fingolimod hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 208005

Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Jan 19, 2021	TE:		RLD:	No

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