Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218459
Company: AUROBINDO PHARMA LTD

Products on ANDA 218459

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SIPONIMOD	SIPONIMOD	EQ 0.25MG BASE	TABLET;ORAL	Prescription	AB	No	No
SIPONIMOD	SIPONIMOD	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No
SIPONIMOD	SIPONIMOD	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218459

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218459

SIPONIMOD

TABLET;ORAL; EQ 0.25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAYZENT	SIPONIMOD	EQ 0.25MG BASE	TABLET;ORAL	Prescription	Yes	AB	209884	NOVARTIS
SIPONIMOD	SIPONIMOD	EQ 0.25MG BASE	TABLET;ORAL	Prescription	No	AB	218459	AUROBINDO PHARMA LTD

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAYZENT	SIPONIMOD	EQ 1MG BASE	TABLET;ORAL	Prescription	Yes	AB	209884	NOVARTIS
SIPONIMOD	SIPONIMOD	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218459	AUROBINDO PHARMA LTD

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAYZENT	SIPONIMOD	EQ 2MG BASE	TABLET;ORAL	Prescription	Yes	AB	209884	NOVARTIS
SIPONIMOD	SIPONIMOD	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218459	AUROBINDO PHARMA LTD