APPLICATION
ANDA075734
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-29
LATEST ACTION
2002-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROXYUREADiscontinued
HYDROXYUREA 1GM · TABLET · ORAL
Approval history
2002-01-18Manufacturing (CMC) · Supplement 1AP
2001-09-27Labeling · Supplement 2AP
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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