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Back to FDA Applications sponsored by RECKITT BENCKISER
FDA Drug Application 021585 by RECKITT BENCKISER
Application Number
021585
Application Type
New Drug Application
Sponsor Applicant
RECKITT BENCKISER
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
Therapeutic Potential
Standard
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
6/22/2004
N
9535
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21585ltr.pdf
6/25/2004
AP
0
6/22/2004
N
9556
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21585_mucinex_lbl.pdf
6/25/2004
AP
0
6/22/2004
N
13192
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021585s000_MucinexTOC.cfm
12/1/2005
AP
0
2/23/2005
SCP
11185
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s001ltr.pdf
3/3/2005
AP
0
1/24/2005
SCP
11025
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf
1/26/2005
AP
0
9/6/2007
SCF
17784
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf
9/7/2007
AP
0
9/6/2007
SCF
17806
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf
9/7/2007
AP
0
12/20/2010
SCM
27353
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021585s025ltr.pdf
12/22/2010
AP
0
5/12/2011
SCM
38710
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf
3/7/2014
AP
0
8/2/2013
SCM
Back to FDA Applications sponsored by RECKITT BENCKISER