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FDA Drug Application 050819 by DOW PHARM

Application Number050819
Application Type New Drug Application
Sponsor ApplicantDOW PHARM
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
AP010/21/2008N21100000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050819s000ltr.pdf 10/29/2008
AP010/21/2008N21201000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf 11/7/2008
AP010/21/2008N23697000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819_acanya_toc.cfm 10/29/2009
AP010/21/2008N23698000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819s000_SumR_P1.pdf 10/29/2009
AP06/23/2010SLR25838002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s002ltr.pdf 6/29/2010
AP06/23/2010SLR25886002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf 7/1/2010
AP010/18/2010SLR26691003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf 10/18/2010
AP010/18/2010SLR26723003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s003ltr.pdf 10/20/2010
AP012/18/2012SCM       
AP02/28/2014SLR38649010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf 3/4/2014
AP02/28/2014SLR38663010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s010ltr.pdf 3/5/2014
AP03/18/2014SCM       
AP011/24/2014SE841089012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s012ltr.pdf 11/26/2014
AP011/24/2014SE841091012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf 11/26/2014
AP09/10/2015SCM       
AP011/19/2015SCM       
AP010/8/2015SCM       
AP03/25/2016SCM       




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