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Last Updated: December 15, 2025

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 021092

Tradename:	HELICOSOL
Applicant:	Metabolic Solutions
Ingredient:	urea c-13
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	125MG/VIAL
Approval Date:	Dec 17, 1999	TE:		RLD:	No

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