Drugs
-
Rulemaking History for OTC Antihistamine Drug Products
|
Final Monograph (21 CFR part 341): |
OTC Antihistamine Drug Products found on this page:
- Original Active Ingredients and Labeling
- Nonmonograph Ingredients
- Chlorcyclizine HCl, Doxylamine Succinate, and Triprolidine HCl
- Combination Products
- Common Cold
- Diphenhydramine Warnings
- Phenylpropanolamine (PPA)
- Pediatric Use
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 9/9/1976 | 41FR38312 |
| Reopening of Administrative Record [PDF] | 3/21/1980 | 45FR18400 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 1/15/1985 | 50FR2200 |
| Correction [PDF] | 2/14/1985 | 50FR6199 |
| Correction [PDF] | 3/6/1985 | 50FR9040 |
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 5/16/1990 | 55FR20434 |
| Correction [PDF] | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 11/7/1990 | 55FR46914 |
| Correction [PDF] | 12/3/1990 | 55FR49973 |
| Technical Amendment: Correct an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
| Final Monograph [PDF] | 12/9/1992 | 57FR58356 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 5/16/1990 | 55FR20434 |
| Correction [PDF] | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 11/7/1990 | 55FR46914 |
| Correction [PDF] | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 8/24/1987 | 52FR31892 |
| Correction [PDF] | 9/22/1987 | 52FR35610 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 1/28/1994 | 59FR4216 |
| Correction [PDF] | 2/14/1997 | 62FR6866 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 8/12/1988 | 53FR30522 |
| Clarification: Promethazine HCl combinations [PDF] | 11/14/1988 | 53FR45774 |
| Proposed Rule: Diphenhydramine citrate and HCl combinations [PDF] | 2/23/1995 | 60FR10286 |
| Notice: Prohibits interim marketing of promethazine HCl combinations [PDF] | 9/5/1989 | 54FR36762 |
| Reopening of Administrative Record: Promethazine HCl combinations [PDF] | 11/28/1989 | 54FR48914 |
| Correction [PDF] | 1/4/1990 | 55FR310 |
| Extension of Comment Period [PDF] | 1/24/1990 | 55FR2387 |
| Final Rule | Date | FR Citation |
| Final Rule: Diphenhydramine citrate and HCl combinations [PDF] | 4/9/1996 | 61FR15700 |
| Final Rule [PDF] | 12/23/2002 | 67FR78158 |
| Technical Amendment: Correction [PDF] | 3/19/2007 | 72FR12730 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Reopening of Administrative Record [PDF] | 8/25/2000 | 65FR51780 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 8/29/1997 | 62FR45767 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 12/6/2002 | 67FR72555 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Notice: Advisory Committee meeting [PDF] | 8/30/2000 | 65FR52775 |
| Notice: Hearing on NDA withdrawal [PDF] | 8/14/2001 | 66FR42665 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Notice: Advisory Committee Meeting [PDF] | 8/16/2007 | 72FR46091 |
| Notice of Public Hearing: Request for comments [PDF] | 8/25/2008 | 73FR50033 |
| Notice of Public Hearing: Correction [PDF] | 9/2/2008 | 73FR51309 |
-
-
