Drug application

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (EMTRICITABINE, TENOFOVIR ALAFENAMIDE)

Drugs@FDA ANDA 211148 · MYLAN LABS LTD

Key facts

Drug name EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Active ingredients EMTRICITABINE, TENOFOVIR ALAFENAMIDE
Application type ANDA
Application number 211148
Company MYLAN LABS LTD
Dosage forms TABLET, ORAL
Strength 200MG/25MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Jan 2, 2024

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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