Drugs

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
FDA Archive-It webpage:

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OTC Allergy Drug Products found on this page:

Allergy Drug Products: Antihistamines for Cold Symptoms

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/9/1976 41FR38312
    Reopening of Administrative Record 3/21/1980 45FR18400
Notice: Advisory Committee meeting 4/29/1983 48FR19470
Notice: Republication of 4/29/1983 notice 5/6/1983 48FR20502
Proposed Rule Date FR Citation
Proposed Rule 1/15/1985 50FR2200
    Correction 2/14/1985 50FR6199
    Correction 3/6/1985 50FR9040
Final Rule Date FR Citation
Final Rule 12/9/1992 57FR58356

Allergy Drug Products: Chlorocyclizine HCl and Doxylamine Succinate

Proposed Rule Date FR Citation
Proposed Rule: Chlorocyclizine HCl and doxylamine succinate 8/24/1987 52FR31892
    Correction 9/22/1987 52FR35610
Final Rule Date FR Citation
Final Rule: doxylamine succinate 1/28/1994 59FR4216

 Allergy Drug Products: Bronchodilators for Asthma Symptoms

Proposed Rule Date FR Citation
Tentative Final Monograph 10/26/1982 47FR47520
Notice: Advisory Committee meeting on metaproterenol 4/29/1983 48FR19470
Notice: Advisory Committee meeting on metaproterenol 5/6/1983 48FR20502

 

 

Page Last Updated: 11/29/2016
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