Details for New Drug Application (NDA): 020584

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NDA 020584 describes LODINE XL, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the LODINE XL profile page.

The generic ingredient in LODINE XL is etodolac. There are twenty-three drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the etodolac profile page.

Summary for 020584

Tradename:	LODINE XL
Applicant:	Wyeth Pharms Inc
Ingredient:	etodolac
Patents:	0

Medical Subject Heading (MeSH) Categories for 020584

Cyclooxygenase 2 Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 25, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 25, 1996	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 20, 1998	TE:		RLD:	No

Expired US Patents for NDA 020584

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-001	Oct 25, 1996	4,966,768*PED	⤷ Subscribe
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998	4,966,768*PED	⤷ Subscribe
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996	4,966,768*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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