Rulemaking History for OTC Antihistamine Drug Products

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research

Rulemaking History for OTC Antihistamine Drug Products
View by Date

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

OTC Antihistamine Drug Products found on this page:

Note: This page links to PDF files which require the free Adobe Acrobat Reader.

**Antihistamine Drug Products: Original Active Ingredients and Labeling**
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
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/15/1985	50FR2200
Correction	2/14/1985	50FR6199
Correction	3/6/1985	50FR9040
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Correct an ingredient name	1/30/1992	57FR3526
Final Monograph	12/9/1992	57FR58356

**Antihistamine Drug Products: Nonmonograph Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526

**Antihistamine Drug Products: Combination Products**
Proposed Rule	Date	FR Citation
Proposed Rule	8/12/1988	53FR30522
Clarification: Promethazine HCl combinations	11/14/1988	53FR45774
Proposed Rule: Diphenhydramine citrate and HCl combinations	2/23/1995	60FR10286
Notice: Prohibits interim marketing of promethazine HCl combinations	9/5/1989	54FR36762
Reopening of Administrative Record: Promethazine HCl combinations	11/28/1989	54FR48914
Correction	1/4/1990	55FR310
Extension of Comment Period	1/24/1990	55FR2387
Final Rule	Date	FR Citation
Final Rule: Diphenhydramine citrate and HCl combinations	4/9/1996	61FR15700
Final Rule	12/23/2002	67FR78158
Technical Amendment: Correction	3/19/2007	72FR12730

**Antihistamine Drug Products: Common Cold**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	8/25/2000	65FR51780

**Antihistamine Drug Products: Phenylpropanolamine (PPA)**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Notice: Advisory Committee meeting	8/30/2000	65FR52775
Notice: Hearing on NDA withdrawal	8/14/2001	66FR42665

**Antihistamine Drug Products: Pediatric Use**
Proposed Rule	Date	FR Citation
Notice: Advisory Committee Meeting	8/16/2007	72FR46091
Notice of Public Hearing; Request for comments	8/25/2008	73FR50033
Notice of Public Hearing: Correction	9/1/2008	73FR51309

Date created: December 28, 2006; Last updated: September 5, 2008