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Rulemaking History for OTC Daytime Sedative Drug Products
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Final Monograph (21 CFR 310.519):
Drug products marketed as over-the-counter (OTC) daytime sedatives

 

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Daytime Sedative Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 12/8/1975 40FR57292
    Correction 1/8/1976 41FR1498
    Correction 1/26/1976 41FR3745
    Correction 1/30/1976 41FR4600
Proposed Rule Date FR Citation
Tentative Final Monograph 6/13/1978 43FR25544
Final Rule Date FR Citation
Final Monograph 6/22/1979 44FR36378
    Correction 7/15/1980 45FR47422

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

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