Hydroxyzine Pamoate

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jun 3, 1959	VistarilNDA 11795 · New dosage form	Pfizer	10	Discontinued
Nov 15, 1968	VistarilNDA 11459 · New active ingredient	Pfizer	11	Discontinued
Dec 14, 1981	Hydroxyzine PamoateANDA 86183	Sandoz	22	Marketed
Dec 14, 1981	Hydroxyzine PamoateANDA 87479	Sandoz	19	Marketed
Mar 5, 1982	Hydroxyzine PamoateANDA 87761	Ivax Sub Teva Pharms	21	Discontinued
Mar 5, 1982	Hydroxyzine PamoateANDA 87760	Ivax Sub Teva Pharms	19	Discontinued
Jul 1, 1982	Hydroxyzine PamoateANDA 86705	Watson Labs	1	Discontinued
Jul 1, 1982	Hydroxyzine PamoateANDA 86840	Watson Labs	1	Discontinued
Aug 16, 1982	Hydroxyzine PamoateANDA 87767	Watson Labs	4	Discontinued
Aug 16, 1982	Hydroxyzine PamoateANDA 87790	Watson Labs	4	Discontinued
Oct 5, 1982	Hydroxyzine PamoateANDA 86728	Watson Labs	0	Discontinued
Sep 19, 1983	Hydroxyzine PamoateANDA 88392	Vangard	0	Discontinued
Sep 19, 1983	Hydroxyzine PamoateANDA 88393	Vangard	0	Discontinued
Feb 29, 1984	Hydroxyzine PamoateANDA 88593	Duramed Pharms Barr	5	Discontinued
Feb 29, 1984	Hydroxyzine PamoateANDA 88595	Duramed Pharms Barr	3	Discontinued
Jun 15, 1984	Hydroxyzine PamoateANDA 88488	Barr Labs	32	Marketed
Jun 15, 1984	Hydroxyzine PamoateANDA 88496	Barr	30	Marketed
Jun 15, 1984	Hydroxyzine PamoateANDA 88487	Barr Labs	31	Marketed
Mar 4, 1985	Hy-Pam "25"ANDA 88713	Teva	0	Discontinued
Jan 2, 1987	Hydroxyzine PamoateANDA 89031	Superpharm	2	Discontinued
Jan 2, 1987	Hydroxyzine PamoateANDA 89032	Superpharm	1	Discontinued
Jan 2, 1987	Hydroxyzine PamoateANDA 89033	Superpharm	2	Discontinued
Jun 28, 1991	Hydroxyzine PamoateANDA 81127	Beximco Pharms USA	1	Discontinued
Jun 28, 1991	Hydroxyzine PamoateANDA 81128	Sandoz	1	Discontinued
Jun 28, 1991	Hydroxyzine PamoateANDA 81129	Sandoz	1	Discontinued
Jul 31, 1991	Hydroxyzine PamoateANDA 81165	Watson Labs	8	Discontinued
Jul 15, 1996	Hydroxyzine PamoateANDA 40156	Impax Labs Inc	6	Marketed
Jun 3, 2013	Hydroxyzine PamoateANDA 201507	Heritage Pharma	2	Marketed
—	Hydroxyzine PamoateANDA 86695	Watson Labs	0	Discontinued
—	Hydroxyzine PamoateANDA 86697	Watson Labs	0	Discontinued
—	Hydroxyzine PamoateANDA 86698	Watson Labs	0	Discontinued
—	Hydroxyzine PamoateANDA 87656	Par Pharm	0	Discontinued
—	Hydroxyzine PamoateANDA 87657	Par Pharm	0	Discontinued
—	Hydroxyzine PamoateANDA 87658	Par Pharm	0	Discontinued
—	Hydroxyzine PamoateANDA 88594	Duramed Pharms Barr	4	Discontinued
—	Hydroxyzine PamoateANDA 89145	Par Pharm	0	Discontinued
—	Hydroxyzine PamoateANDA 89146	Par Pharm	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