Bosentan

ANDA 210342, held by Chartwell Molecular. Bosentan.

As of Nov 14, 2026, ANDA 210342 (Bosentan), held by Chartwell Molecular, was first approved by FDA on Jan 3, 2020, with 0 approved supplements and 0 published complete response letters.

First approved: Jan 3, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 3, 2020	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jan 19, 2023	Supplement 1REMS	Tentative approval	None posted
Jan 3, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 210342
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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