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FDA Drug Application 204200 by PAR STERILE PRODUCTS

Application Number204200
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
AP012/7/2012N34576000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204200s000lbl.pdf 12/10/2012
AP012/7/2012N34777000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204200Orig1s000ltr.pdf 12/27/2012
AP012/7/2012N36831000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200_adrenalin_toc.cfm 8/19/2013
AP012/7/2012N36832000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200Orig1Orig2s000SumR.pdf 8/19/2013
AP07/31/2014SCM       
AP03/3/2015SCM       
AP09/12/2016SCM47050004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s004ltr.pdf 9/15/2016
AP09/12/2016SCM47064004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s004lbl.pdf 9/15/2016
AP05/18/2016SLR46059005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640Orig1s003ltr.pdf 5/19/2016
AP05/18/2016SLR46084005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf 5/20/2016




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