FDA requested companies stop distributing unapproved versions of dehydrated alcohol

The agency approved Belcher Pharmaceuticals LLC’s Ablysinol (dehydrated alcohol), 1 mL and 5 mL ampules (NDC 62250-105) on June 21, 2018. All other dehydrated alcohol products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA, including:

Drug NDC	Product name
17478-503 17478-825	Dehydrated alcohol
0517-8571 0517-8575	Dehydrated alcohol
71414-305 71414-301	Dehydrated alcohol
13925-177	Dehydrated alcohol
52584-575 52584-503	Dehydrated alcohol

FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drug marketed in the United States.

Content current as of:

03/26/2020

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Medically Reviewed By: Felicia Eddings, Pharm.D.

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"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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