Paraplatin

NDA 19880, held by Corden Pharma. Carboplatin.

As of Nov 13, 2026, NDA 19880 (Paraplatin), held by Corden Pharma, was first approved by FDA on Mar 3, 1989, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 3, 1989
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 5, 1991	Supplement 1Efficacy (new indication or use)	Approved	None posted
Mar 3, 1989	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Paraplatin50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Carboplatin	DiscontinuedReference drug
Paraplatin150MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Carboplatin	DiscontinuedReference drug
Paraplatin450MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Carboplatin	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 5, 2010	Supplement 20Labeling · Standard review	Approved	Letter
Mar 21, 2002	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 14, 2002	Supplement 11Labeling · Standard review	Approved	Letter
Apr 30, 2001	Supplement 16Labeling · Standard review	Approved	None posted
Apr 30, 2001	Supplement 12Labeling · Standard review	Approved	None posted
Nov 2, 2000	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 14, 2000	Supplement 15Manufacturing · Priority review	Approved	None posted
Sep 7, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Dec 3, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Nov 15, 1999	Supplement 10Labeling · Standard review	Approved	None posted
Jan 6, 1998	Supplement 9Labeling · Standard review	Approved	Review
Mar 17, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Feb 23, 1993	Supplement 7Labeling · Standard review	Approved	None posted
Jul 5, 1991	Supplement 1Efficacy (new indication or use)	Approved	None posted
Aug 17, 1990	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 12, 1990	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 3, 1989	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19880
Drugs@FDA: Overview at FDA
Company: Corden Pharma

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