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FDA Drug Application 017858 by PHARMALUCENCE

Application Number017858
Application Type New Drug Application
Sponsor ApplicantPHARMALUCENCE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/17/1978N       
AP05/11/1980SCS       
AP01/27/1982SLR       
AP06/30/1982SCS       
AP01/11/1982SLR       
AP02/26/1985SPD       
AP011/16/1981SCS       
AP09/10/1984SCS       
AP04/29/1985SCM       
AP09/12/1986SES       
AP08/2/1985SCM       
AP04/2/1986SCM       
AP09/22/1989SLR       
AP08/25/1995SCS       
AP08/4/1998SCP       
AP09/13/2002SLR3329024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17858slr024ltr.pdf 9/13/2002
AP07/22/2011SE829607034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017858s034ltr.pdf 7/26/2011
AP07/22/2011SE829608034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858s034lbl.pdf 7/27/2011
AP08/13/2012SE133465035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858s035lbl.pdf 8/15/2012
AP08/13/2012SE133489035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017858Orig1s035ltr.pdf 8/16/2012
AP08/13/2012SE133729035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/017858Orig1s035MedR.pdf 9/12/2012
AP012/14/2012SCM       
AP012/4/2013SCM       
AP09/12/2014SCM       
AP04/22/2016SCM       
AP08/13/2015SCM       
AP09/22/2015SCM       
AP09/28/2015SCM       
AP012/4/2015SCM       




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