Drugs

Rulemaking History for OTC Daytime Sedative Drug Products

Final Monograph (21 CFR 310.519):
Drug products marketed as over-the-counter (OTC) daytime sedatives

Daytime Sedative Drug Products

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/8/197540FR57292disclaimer icon
   Correction1/8/197641FR1498disclaimer icon
   Correction1/26/197641FR3745disclaimer icon
   Correction1/30/197641FR4600disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544disclaimer icon
Final RuleDateFR Citation
Final Monograph6/22/197944FR36378disclaimer icon
   Correction7/15/198045FR47422disclaimer icon

Page Last Updated: 02/23/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English