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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


Date Federal Register Citation Description

12/8/1975

40FR57292 PDF document

Advance Notice of Proposed Rulemaking

1/8/1976

41FR1498 PDF document

Correction: Advance Notice of Proposed Rulemaking

1/26/1976

41FR3745 PDF document

Correction: Advance Notice of Proposed Rulemaking

1/30/1976

41FR4600 PDF document

Correction: Advance Notice of Proposed Rulemaking

6/13/1978

43FR25544 PDF document

Tentative Final Monograph

6/22/1979

44FR36378 PDF document

Final Monograph

7/15/1980

45FR47422 PDF document

Correction: Final Monograph

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Date updated: May 9, 2007

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