Rulemaking History for OTC Leg Muscle Cramp Drug Products

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/1/198247FR43562
Proposed RuleDateFR Citation
Tentative Final Monograph11/8/198550FR46588
Final RuleDateFR Citation
Final Monograph8/22/199459FR43234
    Notice: Enforcement Action12/15/200671FR75557


Page Last Updated: 07/11/2017
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