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Generated: November 18, 2018

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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 two suppliers. 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. Two suppliers are 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018689
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)
RIDAURA auranofin CAPSULE;ORAL 018689 NDA Prometheus Laboratories Inc. 65483-093 65483-093-06 60 CAPSULE in 1 BOTTLE (65483-093-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength3MG
Approval Date:May 24, 1985TE:RLD:Yes

Expired US Patents for NDA 018689

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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