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Rulemaking History for OTC Leg Muscle Cramp Drug Products
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Final Monograph (21 CFR 310.546):
Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps

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Leg Muscle Cramp Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 10/1/1982 47FR43562
Proposed Rule Date FR Citation
Tentative Final Monograph 11/8/1985 50FR46588
    Correction 12/2/1985 50FR49409
Final Rule Date FR Citation
Final Monograph 8/22/1994 59FR43234
    Correction 9/28/1994 59FR49350
    Notice: Enforcement Action 12/15/2006 71FR75557

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