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FDA Drug Application 020119 by HQ SPECLT PHARMA

Application Number020119
Application Type New Drug Application
Sponsor ApplicantHQ SPECLT PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/14/1992N       
AP09/28/1992SCS       
AP03/3/1994SCM       
AP010/1/2002SLR2825004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20119slr004ltr.pdf 10/2/2002
AP09/5/1997SCM       
AP08/17/1998SCM       
AP01/28/2000SCM       
AP02/10/2009SLR21829009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020119s009ltr.pdf 2/13/2009
AP010/20/2011SLR30398010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010s011ltr.pdf 10/24/2011
AP010/20/2011SLR30419010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf 10/25/2011
AP010/20/2011SLR30399011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010,s011ltr.pdf 10/24/2011
AP010/20/2011SLR30420011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf 10/25/2011
AP02/26/2013SCM       
AP03/2/2015SLR42023013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020119Orig1s013ltr.pdf 3/5/2015
AP03/2/2015SLR42028013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020119s013lbl.pdf 3/5/2015




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