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FDA Drug Application 016812 by PAR STERILE PRODUCTS

Application Number016812
Application Type New Drug Application
Sponsor ApplicantPAR STERILE PRODUCTS
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
AP02/19/1970N       
AP05/14/1976SLR       
AP01/28/1977SDS       
AP05/16/1977SCS       
AP05/16/1977SLR       
AP07/5/1977SLR       
AP04/4/1980SLR       
AP04/4/1980SCS       
AP08/18/1980SLR       
AP06/11/1982SES       
AP02/7/1989SCS       
AP011/29/1994SCP       
AP02/14/2001SLR       
AP09/5/1997SCP       
AP011/17/1998SCS       
AP03/14/2000SLR       
AP03/29/2000SCS       
AP011/14/2002SLR6293032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16812slr032ltr.pdf 7/31/2003
AP03/7/2012SLR32070039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf 3/9/2012
AP03/7/2012SLR32094039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016812s039ltr.pdf 3/13/2012




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