Details for New Drug Application (NDA): 208452

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NDA 208452 describes EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Laurus and Mylan and is included in two NDAs. It is available from two suppliers. Additional details are available on the EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

Summary for 208452

Tradename:	EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Mylan
Ingredient:	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patents:	0

Pharmacology for NDA: 208452

Mechanism of Action

Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208452

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	208452	ANDA	Mylan Pharmaceuticals Inc.	0378-5440	0378-5440-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE;300MG
Approval Date:	May 20, 2025	TE:	AB	RLD:	No

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