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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213511
Company: AUROBINDO PHARMA

Products on ANDA 213511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELUXADOLINE	ELUXADOLINE	75MG	TABLET;ORAL	Prescription	AB	No	No
ELUXADOLINE	ELUXADOLINE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213511

ELUXADOLINE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELUXADOLINE	ELUXADOLINE	75MG	TABLET;ORAL	Prescription	No	AB	213511	AUROBINDO PHARMA
VIBERZI	ELUXADOLINE	75MG	TABLET;ORAL	Prescription	Yes	AB	206940	ABBVIE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELUXADOLINE	ELUXADOLINE	100MG	TABLET;ORAL	Prescription	No	AB	213511	AUROBINDO PHARMA
VIBERZI	ELUXADOLINE	100MG	TABLET;ORAL	Prescription	Yes	AB	206940	ABBVIE

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