Capecitabine

Treats Stage III colon cancer as a single agent. ANDA 204345, held by Dr Reddys. Capecitabine.

As of Nov 15, 2026, ANDA 204345 (Capecitabine), held by Dr Reddys, was first approved by FDA on Dec 4, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 4, 2020
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Capecitabine tablet 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
Dec 4, 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


May 7, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Mar 31, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jan 14, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Dec 4, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 204345
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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