Capecitabine

ANDA 204741, held by Amneal Pharms. Capecitabine.

As of Nov 15, 2026, ANDA 204741 (Capecitabine), held by Amneal Pharms, was first approved by FDA on Feb 28, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2017
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 28, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Capecitabine150MG · tablet;oral	Capecitabine	Discontinued
Capecitabine500MG · tablet;oral	Capecitabine	Discontinued

All 5 submissions, including labeling and manufacturing supplements


May 7, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Apr 9, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Apr 9, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Apr 9, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Feb 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204741
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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