Linaclotide

ANDA 209564, held by Mylan. Linaclotide.

As of Nov 14, 2026, ANDA 209564 (Linaclotide), held by Mylan, was first approved by FDA on Feb 9, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 9, 2021
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 9, 2021	Original application	Approved	Letter

Products

2 strengths and forms


Linaclotide145MCG · capsule;oral	Linaclotide	Discontinued
Linaclotide290MCG · capsule;oral	Linaclotide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 3, 2024	Supplement 4Labeling · Standard review	Approved	None posted
May 18, 2022	Supplement 1Labeling · Standard review	Approved	None posted
May 18, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Feb 9, 2021	Original application	Approved	Letter

Identifiers

Application: ANDA 209564
Drugs@FDA: Overview at FDA
Company: Mylan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters