Last Updated: November 8, 2026

Details for New Drug Application (NDA): 074942

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NDA 074942 describes ETODOLAC, which is a drug marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Ipca Labs Ltd, Mylan, Natco Pharma, Sandoz, Taro, Actavis Elizabeth, Teva, Unichem, Watson Labs Florida, Zydus Pharms, Adaptis, Amneal Pharms Co, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Pangea, Pharmaco, Pharmazone, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, Tp Anda Holdings, and Watson Labs, and is included in forty NDAs. It is available from thirty suppliers. Additional details are available on the ETODOLAC profile page.

The generic ingredient in ETODOLAC is etodolac. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.

Summary for 074942

Tradename:	ETODOLAC
Applicant:	Sandoz
Ingredient:	etodolac
Patents:	0

Medical Subject Heading (MeSH) Categories for 074942

Cyclooxygenase 2 Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Sep 30, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Sep 30, 1997	TE:		RLD:	No

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