← FDA DRUG APPROVALS

FDA NDA · NDA208843

SIKLOS

hydroxyurea

Sponsor: THERAVIA

APPLICATION
NDA208843
TYPE
NDA
ORIGINAL APPROVAL
2017-12-21
LATEST ACTION
2023-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SIKLOS · ReferencePrescription
HYDROXYUREA 100MG · TABLET · ORAL
SIKLOS · ReferencePrescription
HYDROXYUREA 1GM · TABLET · ORAL

Approval history

2025-01-22Efficacy · Supplement 5 · standard — Letter ↗TA
2023-11-28Labeling · Supplement 4 · standard — Label ↗AP
2021-12-07Efficacy · Supplement 3 · standard — Letter ↗AP
2019-05-22Labeling · Supplement 2 · standard — Letter ↗AP
2018-12-12Labeling · Supplement 1 · standard — Letter ↗AP
2017-12-21Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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