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, 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 thirty-nine NDAs. It is available from twenty-eight 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. Twenty-eight 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	Ipca Laboratories Limited	83980-031	83980-031-01	100 CAPSULE in 1 BOTTLE (83980-031-01)
ETODOLAC	etodolac	CAPSULE;ORAL	205448	ANDA	Ipca Laboratories Limited	83980-031	83980-031-05	500 CAPSULE in 1 BOTTLE (83980-031-05)

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

Complete Access Available with Subscription