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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214095
Company: APOTEX

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/30/2026 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214095Orig1s000ltr.pdf

EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET;ORAL Prescription No AB 214095 APOTEX
ODEFSEY EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET;ORAL Prescription Yes AB 208351 GILEAD SCIENCES INC
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