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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 017628

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NDA 017628 describes TOLECTIN 600, which is a drug marketed by Ortho Mcneil Janssen and is included in one NDA. Additional details are available on the TOLECTIN 600 profile page.

The generic ingredient in TOLECTIN 600 is tolmetin sodium. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.

Summary for 017628

Tradename:	TOLECTIN 600
Applicant:	Ortho Mcneil Janssen
Ingredient:	tolmetin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 017628

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE
Approval Date:	Mar 8, 1989	TE:		RLD:	Yes

Expired US Patents for NDA 017628

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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