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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212420
Company: UPSHER SMITH LABS

Products on ANDA 212420

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 212420

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212420

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	212425	APOTEX
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212369	CIPLA
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212420	UPSHER SMITH LABS

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