Details for New Drug Application (NDA): 204729

NDA 204729 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, Oxford Pharms, Pangea, Pharmaco, Ranbaxy Labs Ltd, Senores Pharms, Shree Hari Intl, Taro Pharm Inds, 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 204729

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

Pharmacology for NDA: 204729

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 204729

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 204729

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETODOLAC	etodolac	TABLET;ORAL	204729	ANDA	Ipca Laboratories Limited	83980-029	83980-029-01	100 TABLET in 1 BOTTLE (83980-029-01)
ETODOLAC	etodolac	TABLET;ORAL	204729	ANDA	Ipca Laboratories Limited	83980-029	83980-029-10	1000 TABLET in 1 BOTTLE (83980-029-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	May 1, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 1, 2024	TE:	AB	RLD:	No

Complete Access Available with Subscription