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FDA NDA · NDA205555

STERITALC 2G

talc

Sponsor: NOVATECH SA

APPLICATION
NDA205555
TYPE
NDA
ORIGINAL APPROVAL
2017-05-01
LATEST ACTION
2025-06-10
ROUTE
INTRAPLEURAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

STERITALC · ReferencePrescription
TALC 4GM/VIAL · POWDER · INTRAPLEURAL
STERITALC · ReferencePrescription
TALC 2GM/VIAL · POWDER · INTRAPLEURAL
STERITALC · ReferencePrescription
TALC 3GM/VIAL · POWDER · INTRAPLEURAL

Approval history

2025-06-10Labeling · Supplement 5 · standardLabelAP
2017-05-01Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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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