Details for New Drug Application (NDA): 075419

NDA 075419 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 075419

Tradename:	ETODOLAC
Applicant:	Apotex
Ingredient:	etodolac
Patents:	0

Pharmacology for NDA: 075419

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 075419

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 075419

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETODOLAC	etodolac	CAPSULE;ORAL	075419	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-294	43353-294-53	60 CAPSULE in 1 BOTTLE (43353-294-53)
ETODOLAC	etodolac	CAPSULE;ORAL	075419	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-294	43353-294-60	90 CAPSULE in 1 BOTTLE (43353-294-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jul 28, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jul 28, 2000	TE:	AB	RLD:	No

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