Drug application

DOLUTEGRAVIR (DOLUTEGRAVIR)

Drugs@FDA ANDA 216731 · STRIDES PHARMA

Key facts

Drug name DOLUTEGRAVIR
Active ingredients DOLUTEGRAVIR
Application type ANDA
Application number 216731
Company STRIDES PHARMA
Dosage forms TABLET, ORAL
Strength 50MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Apr 28, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • None 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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