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  1. Enforcement Activities | FDA

FDA notification regarding dehydrated alcohol

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 NDCProduct name
17478-503
17478-825		Dehydrated alcohol
0517-8571
0517-8575		Dehydrated alcohol
71414-305
71414-301		Dehydrated alcohol
13925-177Dehydrated 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.

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