Carboplatin

ANDA 77139, held by Teva Pharms USA. Carboplatin.

As of Nov 15, 2026, ANDA 77139 (Carboplatin), held by Teva Pharms USA, was first approved by FDA on Sep 21, 2005, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 21, 2005
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
Sep 21, 2005	Original application	Approved	None posted

Products

4 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
Carboplatin600MG/60ML (10MG/ML) · injectable;intravenous	Carboplatin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 14, 2012	Supplement 16Labeling	Approved	Label Letter
Jun 6, 2011	Supplement 6Manufacturing	Approved	None posted
Sep 21, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77139
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals 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