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FDA Drug Application 012911 by HRA PHARMA

Application Number012911
Application Type New Drug Application
Sponsor ApplicantHRA PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/4/1961N       
AP03/2/1976SLR       
AP02/3/1978SCP       
AP04/26/1982SLR       
AP08/29/1984SCS       
AP01/10/1986SLR       
AP02/10/1986SLR       
AP03/26/1992SCS       
AP03/13/1992SLR       
AP06/12/1992SCS       
AP08/9/1995SCS       
AP06/27/1996SCF       
AP02/9/1999SCM       
AP04/21/1999SCP       
AP05/7/2004SLR8556023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12911slr023ltr.pdf 5/7/2004
AP011/4/2010SLR26899026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012911s026ltr.pdf 11/8/2010
AP011/4/2010SLR26913026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf 11/4/2010
AP01/19/2013SCM       
AP06/28/2013SCM       
AP09/20/2013SCM       
AP09/5/2013SCM38656033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012911Orig1s033ltr.pdf 3/4/2014
AP09/5/2013SCM38657033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf 3/4/2014
AP08/14/2014SCM       




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