← FDA DRUG APPROVALS

FDA NDA · NDA212937

PEDMARK

sodium thiosulfate

Sponsor: FENNEC PHARMS INC

APPLICATION
NDA212937
TYPE
NDA
ORIGINAL APPROVAL
2022-09-20
LATEST ACTION
2022-09-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PEDMARK · ReferencePrescription
SODIUM THIOSULFATE 12.5GM/100ML (125MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-09-20Type 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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