Details for New Drug Application (NDA): 210704

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NDA 210704 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 210704

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

Pharmacology for NDA: 210704

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 210704

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 210704

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETODOLAC	etodolac	TABLET;ORAL	210704	ANDA	A-S Medication Solutions	50090-6739	50090-6739-5	60 TABLET, FILM COATED in 1 BOTTLE (50090-6739-5)
ETODOLAC	etodolac	TABLET;ORAL	210704	ANDA	Bryant Ranch Prepack	71335-2259	71335-2259-1	20 TABLET, FILM COATED in 1 BOTTLE (71335-2259-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Dec 16, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Dec 16, 2020	TE:		RLD:	No

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