← FDA DRUG APPROVALS
FDA ANDA · ANDA211640
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA211640
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-09
LATEST ACTION
2023-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 167MG, TENOFOVIR DISOPROXIL FUMARATE 250MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 100MG, TENOFOVIR DISOPROXIL FUMARATE 150MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 133MG, TENOFOVIR DISOPROXIL FUMARATE 200MG · TABLET · ORAL
Approval history
2023-03-09UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.