Omeprazole

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Sep 14, 1989	PrilosecNDA 19810 · New molecular entity	Astrazeneca	89	Discontinued
Nov 1, 2002	OmeprazoleANDA 75410	Lannett Co Inc	27	Marketed
Dec 23, 2002	OmeprazoleANDA 75791	Sandoz	0	Discontinued
Jan 28, 2003	OmeprazoleANDA 75757	Sandoz	24	Marketed
May 29, 2003	OmeprazoleANDA 75876	Strides Pharma	22	Discontinued
Oct 22, 2007	OmeprazoleANDA 75576	Dr Reddys Labs Ltd	18	Marketed
Oct 22, 2007	OmeprazoleANDA 75785	Impax Labs	8	Marketed
Oct 22, 2007	OmeprazoleANDA 76048	Apotex	14	Marketed
Dec 4, 2007	OmeprazoleNDA 22032 · New formulation or manufacturer	Dexcel Pharma	26	Marketed
May 30, 2008	OmeprazoleANDA 75347	Actavis Labs Fl Inc	16	Marketed
Jan 21, 2009	OmeprazoleANDA 76515	Sandoz	18	Marketed
Apr 17, 2009	OmeprazoleANDA 78490	Dr Reddys Labs Ltd	11	Marketed
Nov 19, 2012	OmeprazoleANDA 91352	Zydus Pharms USA Inc	11	Marketed
Oct 31, 2014	OmeprazoleANDA 91672	Glenmark Pharms Ltd	8	Marketed
Aug 19, 2015	OmeprazoleANDA 203270	Aurobindo Pharma	7	Marketed
Aug 25, 2015	OmeprazoleANDA 202384	Lupin	2	Discontinued
Jun 13, 2017	OmeprazoleANDA 204661	Teva Pharms USA	3	Marketed
Jul 3, 2017	OmeprazoleANDA 203481	Breckenridge	4	Marketed
Jul 5, 2017	OmeprazoleNDA 209400 · New dosage form	Dexcel	9	Marketed
Jun 29, 2018	OmeprazoleANDA 205070	Pharmazone	3	Discontinued
Oct 12, 2018	OmeprazoleANDA 207891	Sun Pharm	2	Marketed
Nov 5, 2018	OmeprazoleANDA 207740	Dr Reddys	1	Marketed
Feb 11, 2019	OmeprazoleANDA 210070	Apotex	1	Discontinued
Sep 26, 2019	OmeprazoleANDA 204012	Hetero Labs Ltd Iii	3	Marketed
Dec 10, 2020	OmeprazoleANDA 212977	Xiromed	2	Marketed

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