Bosentan

ANDA 209742, held by Amneal Pharms Co. Bosentan.

As of Nov 14, 2026, ANDA 209742 (Bosentan), held by Amneal Pharms Co, was first approved by FDA on Apr 26, 2019, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2019
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 26, 2019	Original application	Approved	REMS

Products

2 strengths and forms


Bosentan62.5MG · tablet;oral	Bosentan	Discontinued
Bosentan125MG · tablet;oral	Bosentan	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Oct 27, 2026	Supplement 17REMS	Approved	None posted
Jul 23, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Jul 23, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Mar 3, 2026	Supplement 16REMS	Approved	None posted
Nov 5, 2025	Supplement 12REMS	Approved	None posted
Feb 21, 2025	Supplement 10REMS	Approved	None posted
Sep 17, 2024	Supplement 9REMS	Approved	None posted
Jul 11, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jul 11, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 5REMS	Approved	None posted
Nov 4, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Apr 26, 2019	Original application	Approved	REMS

Identifiers

Application: ANDA 209742
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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