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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207945

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NDA 207945 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 nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

Summary for 207945

Tradename:	FINGOLIMOD HYDROCHLORIDE
Applicant:	Ezra Ventures
Ingredient:	fingolimod hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 207945

Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Dec 6, 2023	TE:	AB	RLD:	No

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