Details for New Drug Application (NDA): 018689

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NDA 018689 describes RIDAURA, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the RIDAURA profile page.

The generic ingredient in RIDAURA is auranofin. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the auranofin profile page.

Summary for 018689

Tradename:	RIDAURA
Applicant:	Sebela Ireland Ltd
Ingredient:	auranofin
Patents:	0

Medical Subject Heading (MeSH) Categories for 018689

Antirheumatic Agents

Suppliers and Packaging for NDA: 018689

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIDAURA	auranofin	CAPSULE;ORAL	018689	NDA	Sebela Pharmaceuticals Inc.	54766-093	54766-093-06	60 CAPSULE in 1 BOTTLE (54766-093-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	3MG
Approval Date:	May 24, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 018689

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985	3,635,945	⤷ Subscribe
Sebela Ireland Ltd	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985	4,414,209	⤷ Subscribe
Sebela Ireland Ltd	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985	4,364,923	⤷ Subscribe
Sebela Ireland Ltd	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985	3,708,579	⤷ Subscribe
Sebela Ireland Ltd	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985	4,225,597	⤷ Subscribe
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