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FDA NDA · NDA210850

SINCALIDE

Sponsor: MAIA PHARMS INC

APPLICATION
NDA210850
TYPE
NDA
ORIGINAL APPROVAL
2022-11-22
LATEST ACTION
2023-10-17
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

SINCALIDE · ReferencePrescription
SINCALIDE 0.005MG/VIAL · POWDER · INTRAVENOUS

Approval history

2023-10-17Labeling · Supplement 4 · standardLetterAP
2022-11-22Type 5 - New Formulation or New Manufacturer · Original · priorityLabelAP
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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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