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U.S. Department of Health and Human Services

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Rulemaking History for OTC Allergy Drug Products

Final Monograph (21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
 

OTC Allergy Drug Products found on this page:


Allergy Drug Products: Antihistamines for Cold Symptoms
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/9/197641FR38312
    Reopening of Administrative Record [PDF]3/21/198045FR18400
Notice: Advisory Committee meeting [PDF]4/29/198348FR19470
Notice: Republication of 4/29/1983 notice [PDF]5/6/198348FR20502
Proposed RuleDateFR Citation
Proposed Rule [PDF]1/15/198550FR2200
    Correction [PDF]2/14/198550FR6199
    Correction [PDF]3/6/198550FR9040
Final RuleDateFR Citation
Final Rule [PDF]12/9/199257FR58356

Allergy Drug Products: Chlorocyclizine HCl and Doxylamine Succinate
Proposed RuleDateFR Citation
Proposed Rule: Chlorocyclizine HCl and doxylamine succinate [PDF]8/24/198752FR31892
    Correction [PDF]9/22/198752FR35610
Final RuleDateFR Citation
Final Rule: doxylamine succinate [PDF]1/28/199459FR4216

Allergy Drug Products: Bronchodilators for Asthma Symptoms
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]10/26/198247FR47520
Notice: Advisory Committee meeting on metaproterenol [PDF]4/29/198348FR19470
Notice: Advisory Committee meeting on metaproterenol [PDF]5/6/198348FR20502