Carboplatin

As of Nov 15, 2026, ANDA 77244 (Carboplatin), held by Hikma, was first approved by FDA on Oct 15, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2004
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
Oct 15, 2004	Original application	Approved	Letter

Products

4 strengths and forms


Carboplatin50MG/5ML (10MG/ML) · injectable;intravenous	Carboplatin	Rx
Carboplatin150MG/15ML (10MG/ML) · injectable;intravenous	Carboplatin	Rx
Carboplatin450MG/45ML (10MG/ML) · injectable;intravenous	Carboplatin	Rx
Carboplatin600MG/60ML (10MG/ML) · injectable;intravenous	Carboplatin	Rx

All 6 submissions, including labeling and manufacturing supplements


Mar 13, 2012	Supplement 10Labeling	Approved	None posted
Sep 7, 2011	Supplement 8Labeling	Approved	None posted
Jan 20, 2006	Supplement 2Manufacturing	Approved	None posted
Jan 20, 2006	Supplement 3Labeling	Approved	None posted
Jul 11, 2005	Supplement 1Labeling	Approved	None posted
Oct 15, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 77244
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