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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219788
Company: LAURUS

Products on ANDA 219788

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RILPIVIRINE HYDROCHLORIDE	RILPIVIRINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219788

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219788

RILPIVIRINE HYDROCHLORIDE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDURANT	RILPIVIRINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	202022	JANSSEN PRODS
RILPIVIRINE HYDROCHLORIDE	RILPIVIRINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	219788	LAURUS
RILPIVIRINE HYDROCHLORIDE	RILPIVIRINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	218798	SOMERSET THERAPS LLC

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