Cefprozil

Sold as Cefzil. Every FDA application for this active ingredient: 2 branded and 16 generic.

As of Nov 13, 2026, FDA lists 18 applications for Cefprozil (sold as Cefzil), first approved Dec 23, 1991, with 6 new uses approved and 0 published complete response letters.

First approved: Dec 23, 1991
Applications: 18
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $714K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Cefprozil	Part D	$714K	+0%	18,708

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAPCommunity Acquired Pneumonia in Children · Medical College of Wisconsin	Phase 4	Recruiting	Jul 10, 2024

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Dec 23, 1991	CefzilNDA 50664 · New molecular entity	Corden Pharma	23	Discontinued
Jun 23, 2004	CefzilNDA 50665 · New dosage form	Corden Pharma	23	Discontinued
Nov 14, 2005	CefprozilANDA 65235	Chartwell Rx	3	Marketed
Dec 6, 2005	CefprozilANDA 65208	Teva	2	Marketed
Dec 8, 2005	CefprozilANDA 65236	Chartwell Rx	3	Discontinued
Dec 8, 2005	CefprozilANDA 65257	Sandoz	3	Discontinued
Dec 8, 2005	CefprozilANDA 65276	Lupin	2	Marketed
Dec 19, 2005	CefprozilANDA 65261	Lupin	4	Marketed
Dec 19, 2005	CefprozilANDA 65267	Orchid Hlthcare	2	Discontinued
Dec 30, 2005	CefprozilANDA 65284	Orchid Hlthcare	3	Discontinued
Jun 30, 2006	CefprozilANDA 65202	Ranbaxy Labs Ltd	0	Discontinued
Dec 13, 2006	CefprozilANDA 65198	Ranbaxy Labs Ltd	0	Discontinued
Jan 30, 2007	CefprozilANDA 65381	Aurobindo Pharma	4	Marketed
May 24, 2007	CefprozilANDA 65340	Aurobindo Pharma	2	Marketed
Jun 14, 2007	CefprozilANDA 65428	Wockhardt	1	Discontinued
Mar 26, 2008	CefprozilANDA 65327	Apotex Inc	1	Discontinued
Feb 29, 2012	CefprozilANDA 65351	Apotex Inc	1	Discontinued
Apr 9, 2024	CefprozilANDA 90857	Alkem Labs Ltd	0	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