APPLICATION
ANDA075143
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-16
LATEST ACTION
2024-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription
Products
HYDROXYUREADiscontinued
HYDROXYUREA 250MG · CAPSULE · ORAL
HYDROXYUREAPrescription
HYDROXYUREA 500MG · CAPSULE · ORAL
Approval history
2024-09-23Labeling · Supplement 29 · standardAP
2024-09-23Labeling · Supplement 27 · standardAP
2024-09-23Labeling · Supplement 21 · standardAP
2024-09-23Labeling · Supplement 28 · standardAP
2024-09-23Labeling · Supplement 24 · standardAP
2024-09-23Labeling · Supplement 22 · standardAP
2024-09-23Labeling · Supplement 20 · standardAP
2013-02-27Labeling · Supplement 17AP
2013-02-27Labeling · Supplement 16AP
2011-11-14Labeling · Supplement 15AP
2006-08-15Labeling · Supplement 14AP
2005-04-28Labeling · Supplement 12AP
2001-09-27Labeling · Supplement 9AP
2000-09-21Labeling · Supplement 6AP
2000-09-21Manufacturing (CMC) · Supplement 5AP
2000-05-24Labeling · Supplement 8AP
1999-12-21Manufacturing (CMC) · Supplement 7AP
1999-05-20Manufacturing (CMC) · Supplement 2AP
1999-05-13Manufacturing (CMC) · Supplement 4AP
1999-05-13Manufacturing (CMC) · Supplement 3AP
1999-03-23Manufacturing (CMC) · Supplement 1AP
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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