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Rulemaking History for OTC Oral Fever Blister Drug Products
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Final Monograph (21 CFR 310.537):
Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores

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Oral Fever Blister Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 1/5/1982 47FR502
Proposed Rule Date FR Citation
Tentative Final Monograph 6/17/1985 50FR25156
    Correction 7/15/1985 50FR28595
Final Rule Date FR Citation
Final Monograph 6/30/1992 57FR29166

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Date created: December 28, 2006; Last updated: May 4, 2007
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