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FDA Drug Application 204485 by PAR STERILE PRODUCTS

Application Number204485
Application Type New Drug Application
Sponsor ApplicantPAR STERILE PRODUCTS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/17/2014N39104000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204485Orig1s000ltr.pdf 4/18/2014
AP04/17/2014N40378000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf 9/3/2014
AP04/17/2014N41710000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000TOC.cfm 1/28/2015
AP04/17/2014N41711000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000SumR.pdf 1/28/2015
AP09/18/2014SCM41515001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf 1/7/2015
AP05/7/2015SCM42750002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204485Orig1s002ltr.pdf 5/7/2015
AP05/7/2015SCM42751002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf 5/7/2015
AP03/21/2016SCM       




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