U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Allergy Drug Products
  1. Historical Status of OTC Rulemakings

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 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

 

 
Back to Top