Carboplatin

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Mar 3, 1989	ParaplatinNDA 19880 · New molecular entity	Corden Pharma	16	Discontinued
Jul 14, 2003	ParaplatinNDA 20452 · New dosage form	Cordenpharma	2	Discontinued
Oct 14, 2004	CarboplatinANDA 76099	Hikma	2	Discontinued
Oct 14, 2004	CarboplatinANDA 76162	Watson Labs Teva	0	Discontinued
Oct 14, 2004	CarboplatinANDA 76235	Fresenius Kabi USA	0	Discontinued
Oct 14, 2004	CarboplatinANDA 76517	Hospira	3	Marketed
Oct 14, 2004	CarboplatinANDA 77269	Pharmachemie BV	2	Marketed
Oct 15, 2004	CarboplatinANDA 77244	Hikma	5	Marketed
Oct 21, 2004	CarboplatinANDA 77247	Fresenius Kabi USA	0	Discontinued
Oct 27, 2004	CarboplatinANDA 76473	Hospira	0	Discontinued
Nov 16, 2004	CarboplatinANDA 76602	Pliva	0	Discontinued
Nov 23, 2004	CarboplatinANDA 77059	Hospira	3	Marketed
Mar 18, 2005	CarboplatinANDA 76959	Sandoz	0	Discontinued
Jun 14, 2005	CarboplatinANDA 77096	Meitheal	0	Discontinued
Sep 21, 2005	CarboplatinANDA 77139	Teva Pharms USA	2	Discontinued
Jan 27, 2006	CarboplatinANDA 77383	Cipla Ltd	0	Discontinued
Feb 15, 2006	CarboplatinANDA 77266	Fresenius Kabi USA	1	Marketed
Sep 29, 2006	CarboplatinANDA 77432	Fresenius Kabi USA	3	Discontinued
Jan 18, 2007	CarboplatinANDA 77861	Teyro Labs	2	Marketed
Mar 30, 2007	CarboplatinANDA 77389	Teva Parenteral	0	Discontinued
Apr 24, 2007	CarboplatinANDA 77998	Pharmobedient	0	Discontinued
May 8, 2008	CarboplatinANDA 78280	Sandoz	2	Marketed
Sep 19, 2008	CarboplatinANDA 77926	Sun Pharm	2	Marketed
Dec 2, 2008	CarboplatinANDA 78631	Pliva Lachema	0	Discontinued
Feb 25, 2009	CarboplatinANDA 77679	Pharmachemie BV	0	Discontinued
Jul 29, 2009	CarboplatinANDA 90475	Epic Pharma LLC	0	Marketed
Jul 28, 2010	CarboplatinANDA 91268	Epic Pharma LLC	0	Marketed
Nov 9, 2011	CarboplatinANDA 91063	Pharmobedient	0	Discontinued
Nov 23, 2011	CarboplatinANDA 91478	Pharmobedient	0	Discontinued
Feb 6, 2012	CarboplatinANDA 78732	Actavis Totowa	0	Discontinued
May 29, 2012	CarboplatinANDA 91510	Natco Pharma USA	0	Discontinued
Mar 28, 2016	CarboplatinANDA 205487	Eugia Pharma	0	Marketed
Feb 9, 2017	CarboplatinANDA 206775	Accord Hlthcare	1	Marketed
Feb 15, 2017	CarboplatinANDA 207324	Gland	0	Marketed
Apr 26, 2017	CarboplatinANDA 208487	Ingenus Pharms LLC	0	Discontinued
Aug 8, 2025	KyxataNDA 219921 · New formulation or manufacturer	Avyxa Holdings	0	Marketed
Feb 4, 2026	CarboplatinANDA 219999	Qilu Pharm Hainan	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA