Drug application

ELAGOLIX (ELAGOLIX)

Drugs@FDA ANDA 217668 · ALKEM LABS LTD

Key facts

Drug name ELAGOLIX
Active ingredients ELAGOLIX
Application type ANDA
Application number 217668
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength 150MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Jun 12, 2024

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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