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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. Fifteen suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.

Summary for NDA: 018754

Tradename:
ORUDIS
Applicant:
Wyeth Ayerst
Ingredient:
ketoprofen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 31, 1987TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 9, 1986TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength75MG
Approval Date:Jan 9, 1986TE:RLD:No

Expired Orange Book Patents for NDA: 018754

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Ayerst
ORUDIS
ketoprofen
CAPSULE;ORAL018754-001Jul 31, 19873,641,127► subscribe
Wyeth Ayerst
ORUDIS
ketoprofen
CAPSULE;ORAL018754-003Jan 9, 19863,641,127► subscribe
Wyeth Ayerst
ORUDIS
ketoprofen
CAPSULE;ORAL018754-002Jan 9, 19863,641,127► subscribe
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