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FDA Drug Application 021612 by CIPHER PHARMS INC

Application Number021612
Application Type New Drug Application
Sponsor ApplicantCIPHER PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/11/2006N31336000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/21612s000ltr.pdf 1/24/2006
AP01/11/2006N31337000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf 1/24/2006
AP01/11/2006N31338000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021612_lipofen_toc.cfm 11/17/2008
AP012/12/2008SCP21390002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf 12/19/2008
AP012/12/2008SCA21389004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf 12/19/2008
AP010/31/2011SLR30464007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021612s007ltr.pdf 11/2/2011
AP010/31/2011SLR30477007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf 10/31/2011
AP01/18/2013SCM       
AP01/18/2013SCM34936014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf 1/23/2013
AP01/18/2013SCM34930014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf 1/23/2013
AP01/18/2013SLR34931015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf 1/23/2013
AP01/18/2013SLR34937015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf 1/23/2013
AP012/23/2015SCM       




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