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


Date Federal Register Citation Description
9/9/1976 41FR38312 PDF document Advance Notice of Proposed Rulemaking
3/21/1980 44FR18400 PDF document Reopening of Administrative Record
9/26/1980 44FR63874 PDF document Reopening of Administrative Record
1/15/1985 50FR2200 PDF document Tentative Final Monograph
2/14/1985 50FR6199 PDF document Correction: Tentative Final Monograph
3/6/1985 50FR9040 PDF document Correction: Tentative Final Monograph
8/24/1987 52FR31892 PDF document Proposed Rule: Chlorcyclizine HCl, doxylamine succinate, and tripolidine HCl
9/22/1987 52FR35610 PDF document Correction: 8/24/1987 Proposed Rule
8/12/1988 53FR30522 PDF document Proposed Rule: Combination products
11/14/1988 53FR45774 PDF document Clarification: 8/12/1988 Proposed Rule (Promethazine HCl combinations)
9/5/1989 54FR36762 PDF document Notice: Prohibits interim marketing of promethazine HCl combinations
11/28/1989 54FR48914 PDF document Reopening of Administrative Record: Promethazine HCL combinations
1/4/1990 55FR310 PDF document Correction: 11/28/1989 Reopening of Administrative Record
1/24/1990 55FR2387 PDF document Extension of comment period: 11/28/1989 Reopening of Administrative Record
5/16/1990 55FR20434 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990 55FR23235 PDF document Correction: 5/16/1990 Proposed Rule
11/7/1990 55FR46914 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990 55FR49973 PDF document Correction: 11/7/1990 Final Rule
1/30/1992 57FR3526 PDF document Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
12/9/1992 57FR58356 PDF document Final Monograph
1/28/1994 59FR4216 PDF document Final Rule: Chlorcyclizine HCl, doxylamine succinate, and tripolidine HCl
2/23/1995 60FR10286 PDF document
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Proposed Rule: Diphenhydramine citrate and HCl combinations
4/9/1996 61FR15700 PDF document
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Final Rule: Diphenhydramine citrate and HCl combinations
2/14/1997 62FR6866 PDF document
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Correction: doxylamine succinate
8/29/1997 62FR45767 PDF document
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Proposed Rule: Requires warnings for diphenhydramine
8/25/2000 65FR51780 PDF document
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Reopening of Administrative Record: Common cold
12/6/2002 67FR72555 PDF document
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Final Rule: Requires warnings for diphenhydramine
12/23/2002 67FR78158 PDF document
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Final Rule: Combination products
3/19/2007 72FR12730 PDF document
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Technical Amendment: Correction (12/23/2002 Final Rule)
8/16/2007 72FR46091 Adobe Acrobat Symbol
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Notice: Advisory Committee Meeting

10/1/2007

72R55784 PDF document
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Amendment of Notice: Advisory Committee Meeting
8/25/2008 73FR50033 Adobe Acrobat Symbol
Notice of Public Hearing; Request for comments

9/1/2008

73FR51309 PDF document
Notice of Public Hearing: Correction

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Date updated: September 5, 2008

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