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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 073393

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NDA 073393 describes TOLMETIN SODIUM, which is a drug marketed by Anda Repository, Ani Pharms, Chartwell Rx, Rising, Sun Pharm Industries, and Cosette, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the TOLMETIN SODIUM profile page.

The generic ingredient in TOLMETIN SODIUM is tolmetin sodium. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.

Summary for 073393

Tradename:	TOLMETIN SODIUM
Applicant:	Rising
Ingredient:	tolmetin sodium
Patents:	0

Pharmacology for NDA: 073393

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 073393

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 073393

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073393	ANDA	Rising Pharma Holdings, Inc.	16571-826	16571-826-09	90 CAPSULE in 1 BOTTLE (16571-826-09)
TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073393	ANDA	Atland Pharmaceuticals, LLC	71993-309	71993-309-30	30 CAPSULE in 1 BOTTLE (71993-309-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 400MG BASE
Approval Date:	May 27, 1993	TE:		RLD:	No

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