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FDA Drug Application 017443 by PAR STERILE PRODUCTS

Application Number017443
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
AP01/15/1974N       
AP02/26/1975SCS       
AP011/19/1975SLR       
AP011/20/1975SCS       
AP07/15/1975SLR       
AP010/10/1975SLR       
AP05/12/1976SCP       
AP07/16/1976SCM       
AP05/12/1976SCE       
AP06/15/1977SCF       
AP06/15/1977SLR       
AP010/25/1977SLR       
AP06/27/1977SCF       
AP07/5/1979SCM       
AP08/15/1979SCP       
AP08/15/1979SCP       
AP09/17/1979SCP       
AP03/18/1981SCF       
AP010/9/1981SLR       
AP09/29/1982SLR       
AP011/18/1983SCM       
AP05/16/1983SCS       
AP05/16/1983SCS       
AP05/16/1983SCS       
AP05/16/1983SCS       
AP05/16/1983SCS       
AP05/20/1985SCS       
AP07/23/1985SLR       
AP06/29/1989SCP       
AP02/14/1990SCP       
AP05/20/1991SCS       
AP01/24/1992SCP       
AP07/17/2012SLR33232043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf 7/18/2012
AP07/17/2012SLR33243043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf 7/19/2012
AP09/18/1996SCM       
AP03/14/1997SCS       
AP07/17/2012SLR33233046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf 7/18/2012
AP07/17/2012SLR33244046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf 7/19/2012
AP010/30/1997SCS       
AP07/17/2012SLR33234048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf 7/18/2012
AP07/17/2012SLR33245048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf 7/19/2012
AP07/17/2012SLR33235049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf 7/18/2012
AP07/17/2012SLR33246049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf 7/19/2012
AP03/11/2014SCM       
AP07/8/2015SCM       




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