APPLICATION
NDA021092
TYPE
NDA
ORIGINAL APPROVAL
1999-12-17
LATEST ACTION
2000-10-20
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
HELICOSOLDiscontinued
UREA C-13 125MG/VIAL · FOR SOLUTION · ORAL
Approval history
2000-10-20Manufacturing (CMC) · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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