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FDA Drug Application 205552 by PHARMACYCLICS INC

Application Number205552
Application Type New Drug Application
Sponsor ApplicantPHARMACYCLICS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/13/2013N37823000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf 11/15/2013
AP12/12/2014N37823000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf 11/15/2013
AP011/13/2013N37826000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf 11/15/2013
AP12/12/2014N37826000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf 11/15/2013
AP011/13/2013N37912000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000TOC.cfm 11/25/2013
AP12/12/2014N37912000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000TOC.cfm 11/25/2013
AP011/13/2013N37913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000SumR.pdf 11/25/2013
AP12/12/2014N37913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000SumR.pdf 11/25/2013
AP011/13/2013N38512000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf 2/12/2014
AP12/12/2014N38512000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf 2/12/2014
AP011/13/2013N38513000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig2s000ltr.pdf 2/13/2014
AP12/12/2014N38513000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig2s000ltr.pdf 2/13/2014
AP011/13/2013N42500000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000TOC.cfm 4/13/2015
AP12/12/2014N42500000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000TOC.cfm 4/13/2015
AP011/13/2013N42501000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000SumR.pdf 4/13/2015
AP12/12/2014N42501000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000SumR.pdf 4/13/2015
AP07/28/2014SE840027001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig1s001ltr.pdf 7/29/2014
AP07/28/2014SE840040001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf 7/29/2014
AP01/29/2015SE841712002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf 1/29/2015
AP01/29/2015SE841715002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205552Orig1s002ltr.pdf 1/29/2015
AP08/13/2015SCM       
AP08/17/2015SCM       
AP08/24/2015SCM       
AP03/21/2016SCM       
AP03/4/2016S45390007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s007ltr.pdf 3/8/2016
AP03/4/2016S45395007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf 3/8/2016
AP02/8/2016SCM       
AP011/25/2015SCM       
AP05/6/2016SE845889010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s010,s013ltr.pdf 5/9/2016
AP05/6/2016SE845892010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf 5/9/2016
AP04/13/2016SCM       
AP06/28/2016SLR46439012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s012ltr.pdf 6/29/2016
AP06/28/2016SLR46538012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf 7/18/2016
AP05/6/2016SE845893013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf 5/9/2016
AP06/27/2016SCM       
AP08/15/2016SCM       




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