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FDA NDA · NDA020587

SCLEROSOL

Sponsor: SCIARRA LABS

APPLICATION
NDA020587
TYPE
NDA
ORIGINAL APPROVAL
1997-12-24
LATEST ACTION
2012-10-18
ROUTE
INTRAPLEURAL
DOSAGE FORM
AEROSOL
MARKETING STATUS
Prescription

Products

SCLEROSOL · ReferencePrescription
TALC 4GM/SPRAY · AEROSOL · INTRAPLEURAL

Approval history

2012-10-18Manufacturing (CMC) · Supplement 6 · priority — Label ↗AP
2001-02-23Manufacturing (CMC) · Supplement 3 · priorityAP
2001-02-23Manufacturing (CMC) · Supplement 2 · priorityAP
2000-02-02Labeling · Supplement 1 · standardAP
1997-12-24Type 1 - New Molecular Entity · Original · priority — Review ↗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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