Details for New Drug Application (NDA): 205448

NDA 205448 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 205448

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

Pharmacology for NDA: 205448

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 205448

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 205448

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETODOLAC	etodolac	CAPSULE;ORAL	205448	ANDA	A-S Medication Solutions	50090-8037	50090-8037-1	21 CAPSULE in 1 BOTTLE (50090-8037-1)
ETODOLAC	etodolac	CAPSULE;ORAL	205448	ANDA	Ipca Laboratories Limited	83980-031	83980-031-01	100 CAPSULE in 1 BOTTLE (83980-031-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Aug 1, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Aug 1, 2024	TE:	AB	RLD:	No

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