Details for New Drug Application (NDA): 018754

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NDA 018754 describes ORUDIS, which is a drug marketed by Wyeth Ayerst and Wyeth Cons and is included in two NDAs. Additional details are available on the ORUDIS profile page.

The generic ingredient in ORUDIS is ketoprofen. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.

Summary for 018754

Tradename:	ORUDIS
Applicant:	Wyeth Ayerst
Ingredient:	ketoprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 018754

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 31, 1987	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 9, 1986	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 9, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 018754

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-001	Jul 31, 1987	⤷ Sign Up	⤷ Sign Up
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-003	Jan 9, 1986	⤷ Sign Up	⤷ Sign Up
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-002	Jan 9, 1986	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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