APPLICATION
ANDA213438
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-08
LATEST ACTION
2024-04-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
HYDROXYUREAPrescription
HYDROXYUREA 500MG · CAPSULE · ORAL
Approval history
2024-04-09Labeling · Supplement 1 · standardAP
2024-04-09Labeling · Supplement 3 · standardAP
2020-04-08UNKNOWN · Original · 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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