Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212463
Company: AIZANT

Products on ANDA 212463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212463Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212463

ELIGLUSTAT TARTRATE

CAPSULE;ORAL; EQ 84MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CERDELGA	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	205494	GENZYME CORP
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212463	AIZANT
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212420	UPSHER SMITH LABS