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FDA Drug Application 050445 by PRECISION DERMAT

Application Number050445
Application Type New Drug Application
Sponsor ApplicantPRECISION DERMAT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/26/1972N       
AP03/1/1983SCS       
AP01/16/1985SCE       
AP010/29/1986SLR       
AP05/1/1987SLR       
AP010/6/1987SLR       
AP02/1/2002SLR3600011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf 2/1/2002
AP04/10/1991SCS       
AP02/1/2002SLR3601013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf 2/1/2002
AP05/12/1992SLR       
AP02/1/2002SLR3602015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf 2/1/2002
AP08/8/1995SLR       
AP02/1/2002SLR3603017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf 2/1/2002
AP08/12/1998SCM       
AP05/31/2002SLR9594019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm 6/29/2004
AP05/31/2002SLR3598019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf 5/31/2002
AP03/26/2001SCM       
AP01/28/2002SCS       
AP02/17/2005SLR11118022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf 2/17/2005
AP05/27/2004SLR8862023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf 6/1/2004
AP05/27/2004SLR8863024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf 6/1/2004
AP09/28/2005SLR12835026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf 9/30/2005
AP09/28/2005SLR12926026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf 10/20/2005
AP01/16/2007SLR15683027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf 1/18/2007
AP01/16/2007SLR15688027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045, 050445s027ltr.pdf 1/18/2007
AP09/14/2010SLR26490028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050445s028ltr.pdf 9/16/2010
AP09/14/2010SLR26510028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf 9/20/2010
AP02/25/2015SLR41943029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050445Orig1s029ltr.pdf 2/27/2015
AP02/25/2015SLR41962029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050445s029lbl.pdf 3/2/2015




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