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Generated: September 20, 2017

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Details for New Drug Application (NDA): 021092

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NDA 021092 describes HELICOSOL, which is a drug marketed by Metabolic Solutions and is included in one NDA. Additional details are available on the HELICOSOL profile page.

The generic ingredient in HELICOSOL is urea c-13. There are thirty-three drug master file entries for this compound. Additional details are available on the urea c-13 profile page.

Summary for NDA: 021092

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength125MG/VIAL
Approval Date:Dec 17, 1999TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
McKesson
Cipla
Healthtrust
Chinese Patent Office
US Department of Justice
Farmers Insurance
Cerilliant
Daiichi Sankyo

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