Details for New Drug Application (NDA): 208834

NDA 208834 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 208834

Tradename:	ETODOLAC
Applicant:	Amneal Pharms Co
Ingredient:	etodolac
Patents:	0

Pharmacology for NDA: 208834

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 208834

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 208834

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETODOLAC	etodolac	TABLET;ORAL	208834	ANDA	A-S Medication Solutions	50090-3963	50090-3963-0	14 TABLET, FILM COATED in 1 BOTTLE (50090-3963-0)
ETODOLAC	etodolac	TABLET;ORAL	208834	ANDA	A-S Medication Solutions	50090-3963	50090-3963-1	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3963-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jun 7, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 7, 2018	TE:	AB	RLD:	No

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