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FDA Drug Application 011559 by PAR STERILE PRODUCTS

Application Number011559
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/27/1960N       
AP012/11/1969SLR       
AP06/13/1975SLR       
AP05/14/1976SLR       
AP010/4/1979SCS       
AP07/1/1981SCS       
AP07/8/1988SLR       
AP012/18/1992SLR       
AP012/2/1992SLR       
AP06/14/1994SCS       
AP011/2/1995SCP       
AP02/29/1996SCM       
AP07/25/1996SCS       
AP01/30/1998SE3       
AP01/30/1998SE3       
AP012/17/1997SLR       
AP07/13/2001SLR4330032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11559s32ltr.pdf 7/13/2001
AP03/14/2003SCM8799033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11559scm033ltr.pdf 5/28/2004
AP05/27/2004SLR8848037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf 6/1/2004
AP05/27/2004SLR8876037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11559slr037ltr.pdf 6/1/2004
AP05/5/2008SLR19784041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011559s041ltr.pdf 5/8/2008
AP05/5/2008SLR19992041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf 6/12/2008
AP01/23/2014SLR38365045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011559Orig1s045ltr.pdf 1/24/2014
AP01/23/2014SLR38384045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf 1/28/2014
AP09/22/2014SCM       
AP012/15/2014SCM       




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