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FDA Drug Application 021585 by RECKITT BENCKISER

Application Number021585
Application Type New Drug Application
Sponsor ApplicantRECKITT BENCKISER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/22/2004N13192000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021585s000_MucinexTOC.cfm 12/1/2005
AP06/22/2004N9535000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21585ltr.pdf 6/25/2004
AP06/22/2004N9556000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21585_mucinex_lbl.pdf 6/25/2004
AP02/23/2005SCP11185001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s001ltr.pdf 3/3/2005
AP01/24/2005SCP11025002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf 1/26/2005
AP09/6/2007SCF17784012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf 9/7/2007
AP09/6/2007SCF17806012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf 9/7/2007
AP012/20/2010SCM27353025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021585s025ltr.pdf 12/22/2010
AP05/12/2011SCM38710026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf 3/7/2014
AP08/2/2013SCM       




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