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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208452
Company: MYLAN

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/20/2025 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208452Orig1s000TAltr.pdf

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 208452 MYLAN
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