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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208005
Company: MYLAN

Products on ANDA 208005

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208005

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208005

FINGOLIMOD HYDROCHLORIDE

CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207991	ACCORD HLTHCARE
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	208004	ALKEM LABS LTD
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207993	APOTEX
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207979	BIOCON LTD
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	210252	BIONPHARMA
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	208000	DR REDDYS
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207985	GLENMARK PHARMS LTD
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207939	HEC PHARM CO LTD
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207933	HETERO LABS LTD V
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	208005	MYLAN
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	208003	PRINSTON INC
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	208014	SUN PHARM
FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207994	ZYDUS PHARMS
GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022527	NOVARTIS

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