← FDA DRUG APPROVALS
FDA ANDA · ANDA216914
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Sponsor: CIPLA LTD
APPLICATION
ANDA216914
TYPE
ANDA
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 30MG · TABLET
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 200MG · TABLET
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 120MG · TABLET
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 25MG · TABLET
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 15MG · TABLET
Approval history
2025-06-24UNKNOWN · Original · standardTA
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.