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FDA NDA · NDA203923

SODIUM THIOSULFATE

Sponsor: HOPE PHARMS

APPLICATION
NDA203923
TYPE
NDA
ORIGINAL APPROVAL
2012-02-14
LATEST ACTION
2026-05-07
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SODIUM THIOSULFATE · ReferencePrescription
SODIUM THIOSULFATE 12.5GM/50ML (250MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-05-07Manufacturing (CMC) · Supplement 5AP
2020-06-19Labeling · Supplement 4 · standard — Letter ↗AP
2017-10-19Labeling · Supplement 1 · standard — Letter ↗AP
2012-02-14Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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