Details for New Drug Application (NDA): 018922

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NDA 018922 describes LODINE, which is a drug marketed by Wyeth Pharms Inc and is included in two NDAs. Additional details are available on the LODINE profile page.

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

Summary for 018922

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

Medical Subject Heading (MeSH) Categories for 018922

Cyclooxygenase 2 Inhibitors

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 31, 1991	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jan 31, 1991	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 29, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 018922

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991	3,939,178	⤷ Get Started Free
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	4,076,831	⤷ Get Started Free
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-004	Jul 29, 1993	4,076,831	⤷ Get Started Free
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	3,939,178	⤷ Get Started Free
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991	4,076,831	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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