Carboplatin

ANDA 77432, held by Fresenius Kabi USA. Carboplatin.

As of Nov 15, 2026, ANDA 77432 (Carboplatin), held by Fresenius Kabi USA, was first approved by FDA on Sep 29, 2006, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2006
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 29, 2006	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 30, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Feb 1, 2012	Supplement 3Labeling	Approved	None posted
Jul 22, 2011	Supplement 5Labeling	Approved	None posted
Sep 29, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77432
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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