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FDA Drug Application 017530 by PAR STERILE PRODUCTS

Application Number017530
Application Type New Drug Application
Sponsor ApplicantPAR STERILE PRODUCTS
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
AP07/12/1974N       
AP05/12/1975SCS       
AP012/18/1975SCS       
AP09/25/1980SCM       
AP09/15/1981SLR       
AP02/20/1986SCS       
AP012/3/1998SCM       
AP010/22/1999SCM       
AP010/28/1999SCE       
AP012/14/1999SCM       
AP02/23/2001SCM       
AP04/30/2002SLR9476018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17529s009ltr.pdf 6/18/2004
AP04/30/2002SLR9477018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531s10lbl.pdf 6/18/2004
AP04/30/2002SLR17160018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017530_S018_TIGAN_AP.pdf 7/9/2007
AP06/28/2002SCM       
AP08/26/2005SCF12678021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf 8/31/2005
AP08/26/2005SCF12682021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf 8/31/2005
AP08/26/2005SCP12679022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf 8/31/2005
AP08/26/2005SCP12683022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf 8/31/2005
AP08/26/2005SCM12680023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf 8/31/2005
AP08/26/2005SCM12684023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf 8/31/2005
AP04/18/2008SLR19681024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017530s024ltr.pdf 4/22/2008
AP04/18/2008SLR19955024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017530s024lbl.pdf 6/5/2008




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