Capecitabine

ANDA 200483, held by Hikma. Capecitabine.

As of Nov 15, 2026, ANDA 200483 (Capecitabine), held by Hikma, was first approved by FDA on Jul 14, 2016, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2016
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 14, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Jun 8, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Aug 12, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Oct 15, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Dec 11, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Dec 11, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Jul 14, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 200483
Drugs@FDA: Overview at FDA
Company: Hikma

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