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FDA NDA · NDA214581

SOVUNA

hydroxychloroquine sulfate

Sponsor: NOVITIUM PHARMA

APPLICATION
NDA214581
TYPE
NDA
ORIGINAL APPROVAL
2022-01-14
LATEST ACTION
2024-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SOVUNA · ReferencePrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL
SOVUNA · ReferencePrescription
HYDROXYCHLOROQUINE SULFATE 300MG · TABLET · ORAL

Approval history

2024-10-10Labeling · Supplement 11 · standard — Label ↗AP
2023-09-14Labeling · Supplement 6 · standard — Letter ↗AP
2023-07-24Labeling · Supplement 7 · standard — Letter ↗AP
2023-01-12Labeling · Supplement 4 · standard — Letter ↗AP
2022-01-14Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
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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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