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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218798
Company: SOMERSET THERAPS LLC

Products on ANDA 218798

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RILPIVIRINE	RILPIVIRINE	2.5MG	TABLET	None (Tentative Approval)	None	No	No
RILPIVIRINE HYDROCHLORIDE	RILPIVIRINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218798

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218798

RILPIVIRINE

There are no Therapeutic Equivalents.

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	218798	SOMERSET THERAPS LLC

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