Drug application

NALOXEGOL (NALOXEGOL)

Drugs@FDA ANDA 212625 · MSN LABS PVT LTD

Key facts

Drug name NALOXEGOL
Active ingredients NALOXEGOL
Application type ANDA
Application number 212625
Company MSN LABS PVT LTD
Dosage forms TABLET, ORAL
Strength 12.5MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Feb 24, 2021

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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