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FDA Unapproved Drugs Marketed in the US

Related Documents:
FDA Unapproved Drug List.doc

FDA US Food and Drug Administration

Unapproved Prescription Cough, Cold, and Allergy Products

The drug products on this list were obtained from the Drug Registration and Listing System (DRLS) in December 2010. For more DRLS Information1.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA (21 U.S.C. § 360 and 21 CFR 207). Many drug firms do not update their drug listing information with FDA as required by law; consequently, the information in DRLS is both over- and under-inclusive. Therefore, the list above of unapproved prescription cough/cold/allergy drug products may include drugs that are no longer being marketed and/or may not include prescription cough/cold/allergy drug products that are currently being marketed if the drug firm has not listed or updated their information with DRLS. Any unapproved prescription oral cough/cold/allergy drugs that are not on this list are not entitled to any grace period and are subject to immediate enforcement action.