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FDA Drug Application 019452 by HILL DERMAC

Application Number019452
Application Type New Drug Application
Sponsor ApplicantHILL DERMAC
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
AP02/3/1988N       
AP09/8/1988SCM       
AP03/15/1989SCM       
AP06/27/1989SCM       
AP01/10/1990SCM       
AP010/16/1990SCM       
AP08/27/1996SCS       
AP06/25/1992SCP       
AP02/16/1995SLR       
AP02/16/1995SE1       
AP01/30/1996SCM       
AP04/26/1996SCM       
AP02/4/1997SCM       
AP08/18/1999SE11003015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19452s15ltr.pdf 8/18/1999
AP08/18/1999SE11004015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19452S15_DermaSmooth.cfm 8/18/1999
AP08/18/1999SE11005015   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19425s15lbl.pdf 8/18/1999
AP011/9/2005SE813063016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf 11/17/2005
AP011/9/2005SE813083016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf 11/18/2005
AP010/10/2001SE51659017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19452s17ltr.pdf 10/10/2001
AP010/10/2001SE51660017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19452s17lbl.pdf 10/10/2001
AP010/10/2001SE51661017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-452S017_DermaSmoothe.cfm 10/10/2001
AP04/21/2003SCP5660018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19452scp018_dermasmoothe_lbl.pdf 5/29/2003
AP04/21/2003SCP5714018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19452scp018ltr.pdf 5/29/2003
AP011/9/2005SE813084019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf 11/18/2005
AP011/9/2005SE813064019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf 11/17/2005
AP011/9/2005SE813065020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf 11/17/2005
AP011/9/2005SE813085020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf 11/18/2005
AP012/12/2007SE5       




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