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FDA NDA · NDA016295

DROXIA

hydroxyurea

Sponsor: WAYLIS THERAP

APPLICATION
NDA016295
TYPE
NDA
ORIGINAL APPROVAL
1967-12-07
LATEST ACTION
2024-06-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DROXIA · ReferencePrescription
HYDROXYUREA 300MG · CAPSULE · ORAL
HYDREA · ReferencePrescription
HYDROXYUREA 500MG · CAPSULE · ORAL
DROXIA · ReferencePrescription
HYDROXYUREA 400MG · CAPSULE · ORAL
DROXIA · ReferencePrescription
HYDROXYUREA 200MG · CAPSULE · ORAL

Approval history

2024-06-20Labeling · Supplement 59 · standard — Label ↗AP
2023-11-28Labeling · Supplement 58 · standard — Label ↗AP
2023-06-07Labeling · Supplement 57 · standard — Letter ↗AP
2022-01-13Labeling · Supplement 56 · standard — Letter ↗AP
2021-08-05Labeling · Supplement 55 · standard — Label ↗AP
2021-02-09Labeling · Supplement 54 · standard — Letter ↗AP
2019-12-18Labeling · Supplement 52 · standard — Label ↗AP
2019-07-22Labeling · Supplement 51 · standard — Letter ↗AP
2017-12-18Labeling · Supplement 49 · standard — Label ↗AP
2017-12-18Labeling · Supplement 50 · standard — Label ↗AP
2016-03-23Labeling · Supplement 47 · standard — Letter ↗AP
2016-03-23Labeling · Supplement 48 · standard — Label ↗AP
2015-07-16Labeling · Supplement 45 · standard — Letter ↗AP
2015-07-16Labeling · Supplement 46 · standard — Letter ↗AP
2012-01-26Labeling · Supplement 41 · standard — Letter ↗AP
2012-01-26Labeling · Supplement 42 · unknown — Letter ↗AP
2010-05-07Labeling · Supplement 40 · standard — Letter ↗AP
2006-09-19Labeling · Supplement 39 · standard — Letter ↗AP
2004-02-19Labeling · Supplement 37 · standard — Letter ↗AP
2003-06-26Efficacy · Supplement 36 · standard — Letter ↗AP
2001-04-04Labeling · Supplement 34 · standard — Letter ↗AP
2001-02-20Labeling · Supplement 35 · standardAP
2000-01-12Labeling · Supplement 33 · standardAP
1999-08-11Labeling · Supplement 26 · standardAP
1998-11-10Manufacturing (CMC) · Supplement 31 · priorityAP
1998-02-25Manufacturing (CMC) · Supplement 30 · priorityAP
1998-02-25Efficacy · Supplement 29 · priorityAP
1997-05-23Manufacturing (CMC) · Supplement 28 · priorityAP
1997-04-07Manufacturing (CMC) · Supplement 27 · priorityAP
1996-11-25Manufacturing (CMC) · Supplement 25 · priorityAP
1996-10-15Manufacturing (CMC) · Supplement 24 · priorityAP
1996-09-24Labeling · Supplement 23 · standardAP
1996-09-24Labeling · Supplement 11AP
1995-09-05Manufacturing (CMC) · Supplement 19 · priorityAP
1993-03-09Manufacturing (CMC) · Supplement 22 · priorityAP
1992-07-31Manufacturing (CMC) · Supplement 20 · priorityAP
1988-08-25Manufacturing (CMC) · Supplement 18 · priorityAP
1988-05-10Manufacturing (CMC) · Supplement 17 · priorityAP
1987-03-19Manufacturing (CMC) · Supplement 15 · priorityAP
1987-03-19Manufacturing (CMC) · Supplement 13 · priorityAP
VIEW ON DRUGS@FDA ↗

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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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