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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210252
Company: BIONPHARMA

Products on ANDA 210252

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 210252

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210252Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2024	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 210252

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	207983	AUROBINDO PHARMA LTD
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	207945	EZRA VENTURES
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	208008	TEVA PHARMS USA
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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