Capecitabine

Treats Dukes' C colon cancer. ANDA 207456, held by Shilpa. Capecitabine.

As of Nov 15, 2026, ANDA 207456 (Capecitabine), held by Shilpa, was first approved by FDA on Dec 12, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 12, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Capecitabine tablets are 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 5 submissions below

Date	Submission	Status	Documents
Dec 12, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Jan 11, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jan 11, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Oct 10, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Oct 10, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Dec 12, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207456
Drugs@FDA: Overview at FDA
Company: Shilpa

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