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FDA Drug Application 018207 by PRAGMA PHARMS LLC

Application Number018207
Application Type New Drug Application
Sponsor ApplicantPRAGMA PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1981N16496000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP02/1/1982SLR       
AP04/4/1983SCM       
AP09/3/1986SCS       
AP03/25/1985SCF       
AP011/29/1983SCS       
AP010/24/1983SLR       
AP09/27/1985SLR       
AP07/10/1985SCS       
AP09/19/1985SLR       
AP02/26/1986SCM       
AP09/2/1986SE2       
AP04/14/2000SLR       
AP011/7/1988SE2       
AP09/3/1986SCM       
AP01/22/1988SCS       
AP04/14/1988SCS       
AP010/26/1988SCM       
AP03/5/1990SCM       
AP04/14/2000SLR       
AP02/7/1996SCS       
AP06/25/1996SCS       
AP06/25/1996SCS       
AP06/21/1996SCM       
AP03/17/2004SLR7987029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18207slr029ltr.pdf 3/19/2004
AP01/12/2005SLR10976030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18207s030ltr.pdf 1/13/2005
AP01/12/2005SLR10996030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18207s030lbl.pdf 1/13/2005
AP07/17/2014SLR39904031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018207Orig1s031ltr.pdf 7/21/2014




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