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FDA NDA · NDA207987

DEHYDRATED ALCOHOL

alcohol

Sponsor: BPI LABS

APPLICATION
NDA207987
TYPE
NDA
ORIGINAL APPROVAL
2018-06-21
LATEST ACTION
2025-03-03
ROUTE
PERCUTANEOUS, INTRA-ARTERIAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

ABLYSINOL · ReferencePrescription
DEHYDRATED ALCOHOL 99% (5ML) · SOLUTION · INTRA-ARTERIAL
ABLYSINOL · ReferenceDiscontinued
DEHYDRATED ALCOHOL 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRA-ARTERIAL

Approval history

2025-03-03Manufacturing (CMC) · Supplement 2LabelAP
2018-06-21Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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