Fenoprofen Calcium

Sold as Nalfon. Every FDA application for this active ingredient: 2 branded and 32 generic.

As of Nov 15, 2026, FDA lists 34 applications for Fenoprofen Calcium (sold as Nalfon), first approved Mar 16, 1976, with 1 new use approved and 0 published complete response letters.

First approved: Mar 16, 1976
Applications: 34
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $4.1M

Medicare Spending

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


Fenopron	Part D	$4.1M	New	877
Fenoprofen Calcium	Part D	$24K	-76%	22
Nalfon	Part D	$0K	-100%	0

Applications

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


Mar 16, 1976	NalfonNDA 17604 · New molecular entity	Pharmaco	29	Discontinued
Jun 9, 1977	NalfonNDA 17710 · New dosage form	Dista	15	Discontinued
Apr 20, 1988	Fenoprofen CalciumANDA 72326	Dava Pharms Inc	9	Discontinued
May 2, 1988	Fenoprofen CalciumANDA 72274	Ani Pharms	14	Discontinued
Jun 8, 1988	Fenoprofen CalciumANDA 72267	Pharmaco	15	Discontinued
Jun 13, 1988	Fenoprofen CalciumANDA 72407	Watson Labs Teva	10	Discontinued
Jul 19, 1988	Fenoprofen CalciumANDA 72429	Strides Pharma Intl	7	Discontinued
Aug 22, 1988	Fenoprofen CalciumANDA 72437	Par Pharm	3	Discontinued
Aug 22, 1988	Fenoprofen CalciumANDA 72438	Par Pharm	3	Discontinued
Aug 29, 1988	Fenoprofen CalciumANDA 72557	Ivax Sub Teva Pharms	8	Discontinued
Oct 11, 1988	Fenoprofen CalciumANDA 72602	Watson Labs	7	Discontinued
Oct 14, 1988	Fenoprofen CalciumANDA 72395	Rising	4	Discontinued
Oct 17, 1988	Fenoprofen CalciumANDA 72394	Rising	5	Discontinued
Oct 17, 1988	Fenoprofen CalciumANDA 72396	Rising	6	Discontinued
Dec 21, 1990	Fenoprofen CalciumANDA 72902	Sun Pharm Industries	11	Discontinued
Aug 19, 1991	Fenoprofen CalciumANDA 72981	Watson Labs	0	Discontinued
Aug 19, 1991	Fenoprofen CalciumANDA 72982	Watson Labs	0	Discontinued
Jul 18, 2022	Fenoprofen CalciumANDA 214475	Rising	2	Marketed
May 16, 2023	Fenoprofen CalciumANDA 215548	Misemer	0	Marketed
—	Fenoprofen CalciumANDA 71738	Quantum Pharmics	2	Discontinued
—	Fenoprofen CalciumANDA 72165	Watson Labs	0	Discontinued
—	Fenoprofen CalciumANDA 72194	Quantum Pharmics	0	Discontinued
—	Fenoprofen CalciumANDA 72214	Quantum Pharmics	0	Discontinued
—	Fenoprofen CalciumANDA 72293	Watson Labs	0	Discontinued
—	Fenoprofen CalciumANDA 72294	Watson Labs	0	Discontinued
—	Fenoprofen CalciumANDA 72307	Am Therap	0	Discontinued
—	Fenoprofen CalciumANDA 72308	Am Therap	0	Discontinued
—	Fenoprofen CalciumANDA 72309	Am Therap	0	Discontinued
—	Fenoprofen CalciumANDA 72355	Halsey	0	Discontinued
—	Fenoprofen CalciumANDA 72356	Halsey	0	Discontinued
—	Fenoprofen CalciumANDA 72357	Halsey	0	Discontinued
—	Fenoprofen CalciumANDA 72362	Usl Pharma	0	Discontinued
—	Fenoprofen CalciumANDA 72472	Warner Chilcott	0	Discontinued
—	Fenoprofen CalciumANDA 72946	Warner Chilcott	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