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FDA Drug Application 021620 by RECKITT BENCKISER

Application Number021620
Application Type New Drug Application
Sponsor ApplicantRECKITT BENCKISER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/29/2004N12839000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021620s000_MucinexTOC.cfm 10/6/2005
AP04/29/2004N8456000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21620ltr.pdf 5/3/2004
AP04/29/2004N8506000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21620_mucinex_lbl.pdf 5/4/2004
AP01/24/2005SCP11026001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf 1/26/2005
AP01/26/2006SCP13555005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021620s005ltr.pdf 1/30/2006
AP09/6/2007SCF17783011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf 9/7/2007
AP09/6/2007SCF17805011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf 9/7/2007
AP04/3/2009SCP22223021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021620s021ltr.pdf 4/9/2009
AP03/11/2011SCM38706029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s035,021620Orig1s029ltr.pdf 3/7/2014
AP05/12/2011SCM38711031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf 3/7/2014
AP09/5/2014SCM       
AP04/7/2015SCM       




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