Capecitabine

Treats Stage III colon cancer as a single agent. ANDA 211724, held by Somerset Theraps LLC. Capecitabine.

As of Nov 15, 2026, ANDA 211724 (Capecitabine), held by Somerset Theraps LLC, was first approved by FDA on Apr 27, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2020
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer

adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. Breast Cancer
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Apr 27, 2020	Original application	Approved	None posted

Products

2 strengths and forms


Capecitabine150MG · tablet;oral	Capecitabine	Rx
Capecitabine500MG · tablet;oral	Capecitabine	Rx

All 4 submissions, including labeling and manufacturing supplements


Jul 1, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Jul 21, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 21, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Apr 27, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 211724
Drugs@FDA: Overview at FDA
Company: Somerset Therapeutics

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