Carboplatin

As of Nov 15, 2026, ANDA 76099 (Carboplatin), held by Hikma, was first approved by FDA on Oct 14, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 14, 2004
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 14, 2004	Original application	Approved	None posted

Products

3 strengths and forms


Carboplatin50MG/VIAL · injectable;injection	Carboplatin	Discontinued
Carboplatin150MG/VIAL · injectable;injection	Carboplatin	Discontinued
Carboplatin450MG/VIAL · injectable;injection	Carboplatin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 2, 2012	Supplement 6Labeling	Approved	None posted
Sep 7, 2011	Supplement 4Labeling	Approved	None posted
Oct 14, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76099
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