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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220232
Company: LAURUS

Products on ANDA 220232

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE	200MG;EQ 25MG BASE;300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220232

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220232

EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 200MG;EQ 25MG BASE;300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COMPLERA	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE	200MG;EQ 25MG BASE;300MG	TABLET;ORAL	Prescription	Yes	AB	202123	GILEAD SCIENCES INC
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE	200MG;EQ 25MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	220232	LAURUS
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE	200MG;EQ 25MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	208452	MYLAN

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