FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

Rulemaking History for OTC Expectorant 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 Expectorant Drug Products found on this page:

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


Expectorant 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
    Reopening of Administrative Record 9/26/1980 44FR63874
Proposed Rule Date FR Citation
Tentative Final Monograph 7/9/1982 47FR30002
    Extension of Comment Period 8/27/1982 47FR37934
Final Rule Date FR Citation
Final Monograph 2/28/1989 54FR8494
    Correction 3/22/1989 54FR11866
    Technical Amendment: Replaces "sputum" with "mucus" in indication 6/30/1992 57FR29176
Final Rule: Classifies ipecac as nonmonograph 9/14/1992 57FR41857
    Correction 10/8/1992 57FR46067

Expectorant Drug Products: Combination Products
Proposed Rule Date FR Citation
Proposed Rule: Miscellaneous combinations 8/12/1988 53FR30522
    Clarification: Includes promethazine HCl combinations 11/14/1988 53FR45774
Notice: Prohibits OTC 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
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph 7/13/2005 70FR40232

Expectorant Drug Products: Pediatric Use
Proposed Rule Date FR Citation
Notice: Advisory Committee Meeting 8/16/2007 72FR46091
Amendment of Notice: Advisory Committee Meeting 10/1/2007 72FR55784
Notice of Public Hearing; Request for comments 8/25/2008 73FR50033
Notice of Public Hearing: Correction 9/1/2008 73FR51309

top arrow Back to Top     back arrow Back to Rulemaking Index

Date created: December 28, 2006; Last updated: September 8, 2008
horizonal rule

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