Carboplatin

ANDA 78280, held by Sandoz. Carboplatin.

As of Nov 15, 2026, ANDA 78280 (Carboplatin), held by Sandoz, was first approved by FDA on May 8, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: May 8, 2008
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
May 8, 2008	Original application	Approved	None posted

Products

3 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

All 3 submissions, including labeling and manufacturing supplements


Mar 8, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Feb 1, 2010	Supplement 4Labeling	Approved	None posted
May 8, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78280
Drugs@FDA: Overview at FDA
Company: Sandoz

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