Tolmetin Sodium

Sold as Tolectin, Tolectin 600, Tolectin Ds. Every FDA application for this active ingredient: 2 branded and 14 generic.

As of Nov 15, 2026, FDA lists 16 applications for Tolmetin Sodium (sold as Tolectin, Tolectin 600, Tolectin Ds), first approved Mar 24, 1976, with 5 new uses approved and 0 published complete response letters.

First approved: Mar 24, 1976
Applications: 16
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $13.1M

Medicare Spending

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


Tolmetin Sodium	Part D	$7.3M	+173%	1,030
Tolectin 600	Part D	$5.7M	+763%	834

Applications

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


Mar 24, 1976	Tolectin, Tolectin 600NDA 17628 · New molecular entity	Ortho Mcneil Janssen	51	Discontinued
Oct 30, 1979	Tolectin DsNDA 18084 · New dosage form	Ortho Mcneil Janssen	38	Discontinued
Nov 27, 1991	Tolmetin SodiumANDA 73290	Pharmazone	9	Discontinued
Nov 27, 1991	Tolmetin SodiumANDA 73310	Sun Pharm Industries	10	Discontinued
Nov 27, 1991	Tolmetin SodiumANDA 73311	Sun Pharm Industries	10	Discontinued
Jan 24, 1992	Tolmetin SodiumANDA 73308	Ani Pharms	11	Discontinued
Jan 24, 1992	Tolmetin SodiumANDA 73392	Ani Pharms	4	Discontinued
Apr 30, 1992	Tolmetin SodiumANDA 73462	Chartwell Rx	7	Discontinued
May 29, 1992	Tolmetin SodiumANDA 73519	Ani Pharms	7	Discontinued
Jun 30, 1992	Tolmetin SodiumANDA 73527	Ani Pharms	9	Discontinued
Jul 31, 1992	Tolmetin SodiumANDA 73588	Chartwell Rx	5	Discontinued
May 27, 1993	Tolmetin SodiumANDA 73393	Rising	6	Marketed
Sep 27, 1993	Tolmetin SodiumANDA 74002	Chartwell Rx	4	Discontinued
Aug 30, 1994	Tolmetin SodiumANDA 74473	Rising	10	Marketed
Mar 28, 1996	Tolmetin SodiumANDA 74399	Cosette Pharms Nc	4	Discontinued
Feb 27, 1997	Tolmetin SodiumANDA 74729	Cosette Pharms Nc	7	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