Details for New Drug Application (NDA): 021092
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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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