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 Rulemaking9/9/197641FR38312
    Reopening of Administrative Record3/21/198045FR18400
Notice: Advisory Committee meeting4/29/198348FR19470
Notice: Republication of 4/29/1983 notice5/6/198348FR20502
Proposed RuleDateFR Citation
Proposed Rule1/15/198550FR2200
Final RuleDateFR Citation
Final Rule12/9/199257FR58356

Allergy Drug Products: Chlorocyclizine HCl and Doxylamine Succinate

Proposed RuleDateFR Citation
Proposed Rule: Chlorocyclizine HCl and doxylamine succinate8/24/198752FR31892
Final RuleDateFR Citation
Final Rule: doxylamine succinate1/28/199459FR4216

Allergy Drug Products: Bronchodilators for Asthma Symptoms

Proposed RuleDateFR Citation
Tentative Final Monograph10/26/198247FR47520
Notice: Advisory Committee meeting on metaproterenol4/29/198348FR19470
Notice: Advisory Committee meeting on metaproterenol5/6/198348FR20502


Page Last Updated: 02/28/2017
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