Capecitabine

Treats Dukes' C colon cancer. ANDA 209365, held by Msn. Capecitabine.

As of Nov 15, 2026, ANDA 209365 (Capecitabine), held by Msn, was first approved by FDA on Jul 2, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 2, 2018
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 with antineoplastic activity indicated for:

Adjuvant Colon Cancer – Patients with Dukes' C colon cancer
Metastatic Colorectal Cancer – First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
Metastatic Breast Cancer – In combination with docetaxel after failure of prior anthracycline-containing therapy – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen 1.

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
Jul 2, 2018	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


Apr 15, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Apr 15, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Dec 20, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Jul 2, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209365
Drugs@FDA: Overview at FDA
Company: MSN 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