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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 207939

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NDA 207939 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 207939

Tradename:	FINGOLIMOD HYDROCHLORIDE
Applicant:	Hec Pharm Co Ltd
Ingredient:	fingolimod hydrochloride
Patents:	0

Pharmacology for NDA: 207939

Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Medical Subject Heading (MeSH) Categories for 207939

Immunosuppressive Agents

Suppliers and Packaging for NDA: 207939

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207939	ANDA	Rising Pharma Holdings, Inc.	64980-449	64980-449-03	30 CAPSULE in 1 BOTTLE (64980-449-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Nov 10, 2021	TE:	AB	RLD:	No

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