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Urea - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for urea?

Urea is the generic ingredient in eight branded drugs marketed by Hospira, Dxs Devices, Otsuka America, Metabolic Solutions, and Avent, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for urea.

Summary for Generic Name: urea

Drug Master File Entries: see list32
Bulk Api Vendors: see list94
Clinical Trials: see list159
Patent Applications: see list80,822
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:urea at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
urea, c-14
CAPSULE;ORAL020617-002May 9, 1997RXYesYes► Subscribe► Subscribe
INJECTABLE;INJECTION012154-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Otsuka America
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 2001DISCNNoNo► Subscribe► Subscribe
Metabolic Solutions
urea c-13
FOR SOLUTION;ORAL021092-001Dec 17, 1999DISCNNoNo► Subscribe► Subscribe
Otsuka America
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996DISCNNoNo► Subscribe► Subscribe
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