APPLICATION
ANDA074476
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-18
LATEST ACTION
2001-12-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDROXYUREADiscontinued
HYDROXYUREA 500MG · CAPSULE · ORAL
Approval history
2001-12-12Labeling · Supplement 6AP
2001-05-14Manufacturing (CMC) · Supplement 5AP
2000-05-31Manufacturing (CMC) · Supplement 2AP
2000-05-31Manufacturing (CMC) · Supplement 3AP
2000-05-31Labeling · Supplement 4AP
1997-11-20Labeling · Supplement 1AP
1995-08-18OriginalAP
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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