General MedicationsORALGeneric
HELICOSOL
UREA C-13
Standard Dose
125MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview HELICOSOL is listed in Drugs@FDA under application 021092 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient UREA C-13 Form and strength FOR SOLUTION;ORAL - 125MG/VIAL Sponsor METABOLIC SOLUTIONS Submission history Latest submission status date: 2000-10-20 00:00:00.
Structured Monograph
Clinical summary
Approval overview HELICOSOL is listed in Drugs@FDA under application 021092 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient UREA C-13 Form and strength FOR SOLUTION;ORAL - 125MG/VIAL Sponsor METABOLIC SOLUTIONS Submission history Latest submission status date: 2000-10-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.