Final Monograph (21 CFR part 341 ):
OTC Nasal Decongestant Drug Products found on this page:
Advance Notice Of Proposed Rulemaking Date FR CitationAdvance Notice of Proposed Rulemaking 9/9/1976 41FR38312 Reopening of Administrative Record 3/21/1980 45FR18400 Reopening of Administrative Record 9/26/1980 45FR63874 Proposed Rule Date FR CitationTentative Final Monograph 1/15/1985 50FR2220 Notice: Advisory Committee Meeting 10/24/2007 72FR60377 Final Rule Date FR CitationFinal Monograph 8/23/1994 59FR43386 Partial Stay of Effective Date: l-desoxyephedrine 3/8/1996 61FR9570 Final Rule: Adds and renames l-desoxyephedrine to levmetamphetamine 7/30/1998 63FR40647
Proposed Rule Date FR CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434 Correction 6/7/1990 55FR23235 Final Rule Date FR CitationFinal 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
Proposed Rule Date FR Citation Proposed Rule 8/12/1988 53FR30522 Clarification: Promethazine HCL combinations 11/14/1988 53FR45774 Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph 7/13/2005 70FR40232 Final Rule Date FR CitationFinal Rule: nonmonograph combinations 9/27/2001 66FR49276 Correction 10/19/2001 66FR53088 Final Rule: GRASE combinations 12/23/2002 67FR78158 Technical Amendment: Correction 3/19/2007 72FR12730
Proposed Rule Date FR CitationProposed Rule: Adds effervescent tablet as GRASE dosage form 11/2/2004 69FR63482 Notice: Advisory Committee Meeting 10/24/2007 72FR60377 Final Rule Date FR CitationFinal Rule: Adds effervescent tablet as GRASE dosage form 8/1/2006 71FR83358
Final Rule Date FR CitationFinal Rule: Reduces maximum daily dose 9/30/1980 45FR64709 Extension of Effective Date 12/19/1980 44FR83671 Stay 5/5/1981 46FR25144
Proposed Rule Date FR CitationProposed Rule: Revises drug interaction warning 6/19/1992 57FR27658 Correction 7/30/1992 57FR33663 Extension of Comment Period 8/6/1992 57FR34734
Proposed Rule Date FR CitationProposed Rule: Prohibits sinusitis claim 8/2/2004 69FR46119 Final Rule Date FR CitationFinal Rule 10/11/2005 70FR58974
Proposed Rule Date FR CitationNotice: 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 9/2/2008 73FR51309
Proposed Rule Date FR CitationProposed Rule: Clarifies dosage 10/28/1977 42FR56756 Proposed Rule: Required labeling 2/14/1996 61FR5912 Notice: Advisory Committee meeting 8/30/2000 65FR52775 Notice: Hearing on NDA withdrawal 8/14/2001 66FR42665 Proposed Rule: Reclassifies phenylpropanolamine from category I to II 12/22/2005 70FR75988
Advance Notice Of Proposed Rulemaking Date FR CitationReopening of Administrative Record 8/30/1983 48FR39242 Correction 9/19/1983 48FR41786
Content current as of:
03/06/2017
