Nucleoside and nucleotide reverse transcriptase inhibitors

Emtricitabine and Tenofovir Alafenamide

Approved 2 Jan 2024OralTablet

The FDA lists this product in 6 strengths and forms.

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Composition

Active ingredients: EMTRICITABINE, TENOFOVIR ALAFENAMIDE 10MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

EMTRICITABINE, TENOFOVIR ALAFENAMIDE 120MG · TabletANDA211148-004 · Tentative approval
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 15MG · TabletANDA211148-002 · Tentative approval
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 200MG · TabletANDA211148-005 · Tentative approval
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 25MG · TabletANDA211148-003 · Tentative approval
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 10MG · TabletThis page
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 200MG/25MG · TabletANDA211680-001 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA211148.

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At a glance

Brand name: Emtricitabine and Tenofovir Alafenamide
Active substance: emtricitabine, tenofovir alafenamide
Drug class: Nucleoside and nucleotide reverse transcriptase inhibitors, Antivirals for treatment of HIV infections, combinations
Group: Antivirals
Route: Oral
Dosage form: Tablet
Applicant: Mylan Labs LTD
Status: Tentative approval
FDA approval: 2 Jan 2024
Application: ANDA211148-001
RxCUI: 1727491