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FDA Drug Application 021623 by GALEN SPECIALTY

Application Number021623
Application Type New Drug Application
Sponsor ApplicantGALEN SPECIALTY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/2005N11885000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021623ltr.pdf 6/24/2005
AP06/23/2005N11892000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf 6/24/2005
AP06/23/2005N19458000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021623TOC.cfm 3/14/2008
AP03/10/2014SLR38761015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf 3/11/2014
AP03/10/2014SLR38770015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf 3/13/2014
AP03/10/2014SLR38771017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf 3/13/2014
AP03/10/2014SLR38762017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf 3/11/2014
AP010/16/2013SCM       
AP07/9/2013SCM       
AP17/9/2013SCM       
AP01/10/2014SCM       




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