Drug application

LINACLOTIDE (LINACLOTIDE)

Drugs@FDA ANDA 209564 · MYLAN

Key facts

Drug name LINACLOTIDE
Active ingredients LINACLOTIDE
Application type ANDA
Application number 209564
Company MYLAN
Dosage forms CAPSULE, ORAL
Strength 145MCG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Feb 9, 2021

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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