Drug application

BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE)

Drugs@FDA ANDA 218766 · CIPLA LTD

Key facts

Drug name BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Active ingredients BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Application type ANDA
Application number 218766
Company CIPLA LTD
Dosage forms TABLET
Strength 200MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Oct 14, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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