Details for New Drug Application (NDA): 210704

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, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Abraxeolus, Adaptis, Amneal Pharms Co, Apotex Inc, Ivax Sub Teva Pharms, Oxford Pharms, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-nine NDAs. It is available from thirty-one 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-one suppliers are listed for this compound. Additional details are available on the etodolac profile page.

Summary for 210704

Tradename:	ETODOLAC
Applicant:	Bayshore Pharms Llc
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	Preferred Pharmaceuticals Inc.	68788-8580	68788-8580-6	100 TABLET, FILM COATED in 1 BOTTLE (68788-8580-6)

Profile for product number 001

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

Profile for product number 002

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

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