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Rulemaking History for OTC Anticholinergic Drug Products
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Final Monograph (21 CFR 310.533):
Drug Products Containing Active Ingredients Offered Over-the-Counter Human Use as an Anticholinergic in Cough-Cold Drug Products

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Anticholinergic Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/9/1976 41FR38312
Reopening of  Administative Record 3/21/1980 45FR18400
Reopening of Administrative Record: Camphor-containing products 9/26/1980 45FR63874
Proposed Rule Date FR Citation
Tentative Final Monograph 7/9/1982 47FR30002
    Extension of Comment Period: Guaifenesin effectiveness 8/27/1982 47FR37934
Final Rule Date FR Citation
Final Monograph 11/8/1985 50FR46582
    Correction 12/2/1985 50FR49371

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