Rulemaking History for OTC Daytime Sedative Drug Products

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/8/197540FR57292
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544
Final RuleDateFR Citation
Final Monograph6/22/197944FR36378


Page Last Updated: 11/29/2016
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