Details for New Drug Application (NDA): 214872

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NDA 214872 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 214872

Tradename:	ETODOLAC
Applicant:	Aurobindo Pharma Ltd
Ingredient:	etodolac
Patents:	0

Pharmacology for NDA: 214872

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 214872

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 214872

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETODOLAC	etodolac	TABLET;ORAL	214872	ANDA	Aurobindo Pharma Limited	59651-461	59651-461-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-461-01)
ETODOLAC	etodolac	TABLET;ORAL	214872	ANDA	Aurobindo Pharma Limited	59651-462	59651-462-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-462-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jul 15, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 15, 2026	TE:	AB	RLD:	No

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