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Last Updated: March 26, 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, Ivax Sub Teva Pharms, Oxford Pharms, Pangea, Pharmaco, Ranbaxy Labs Ltd, Senores Pharms, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-nine NDAs. It is available from twenty-eight suppliers. Additional details are available on the ETODOLAC profile page.

The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Twenty-eight 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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