Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075009

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NDA 075009 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 075009

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

Medical Subject Heading (MeSH) Categories for 075009

Cyclooxygenase 2 Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Nov 26, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Dec 28, 1999	TE:		RLD:	No

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