Drug application

SUNLENCA (LENACAPAVIR SODIUM)

Drugs@FDA NDA 215974 · GILEAD SCIENCES INC

Key facts

Drug name SUNLENCA
Active ingredients LENACAPAVIR SODIUM
Application type NDA
Application number 215974
Company GILEAD SCIENCES INC
Dosage forms TABLET, ORAL
Strength EQ 300MG BASE
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Dec 22, 2022

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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 · Source date:

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