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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 205448

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NDA 205448 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, Anda Repository, Ivax Sub Teva Pharms, Oxford Pharms, Pangea, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-nine NDAs. It is available from thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.

Summary for 205448

Tradename:	ETODOLAC
Applicant:	Ipca Labs Ltd
Ingredient:	etodolac
Patents:	0

Medical Subject Heading (MeSH) Categories for 205448

Cyclooxygenase 2 Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Aug 1, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Aug 1, 2024	TE:	AB	RLD:	No

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