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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Leg Muscle Cramp Drug Products
  1. Historical Status of OTC Rulemakings

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 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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