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FDA Drug Application 021260 by KING PHARMS LLC

Application Number021260
Application Type New Drug Application
Sponsor ApplicantKING PHARMS LLC
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
AP03/20/2002N4601000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21260ltr.pdf 3/20/2002
AP03/20/2002N4602000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21260lbl.pdf 3/20/2002
AP03/20/2002N7569000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-260_Avinza.cfm 1/15/2004
AP03/20/2002N33124000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP03/20/2002N33125000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311346.pdf 7/11/2012
AP011/8/2002SCM       
AP010/18/2005SLR12955006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021260s006lbl.pdf 10/24/2005
AP010/18/2005SLR12968006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021260s006ltr.pdf 10/25/2005
AP012/18/2008SCS21395013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021260s013ltr.pdf 12/23/2008
AP07/9/2012SLR33117015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021260s015ltr.pdf 7/11/2012
AP07/9/2012SLR33151015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015lbl.pdf 7/12/2012
AP07/9/2012SLR33152015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015mg.pdf 7/12/2012
AP07/9/2012SLR33153016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s016lbl.pdf 7/12/2012
AP07/9/2012SLR33142016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021260Orig1s016ltr.pdf 7/11/2012
AP05/6/2013SLR35948017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021260s017lbl.pdf 5/6/2013
AP05/6/2013SLR35983017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021260Orig1s017ltr.pdf 5/8/2013
AP04/15/2013SLR35709018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021260Orig1s018ltr.pdf 4/16/2013
AP04/16/2014SLR39064022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021260s022lbl.pdf 4/16/2014
AP04/16/2014SLR39071022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021260Orig1s022ltr.pdf 4/17/2014
AP08/19/2014S40272023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021260Orig1s023ltr.pdf 8/20/2014
AP06/26/2015S43228024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021260Orig1s024ltr.pdf 7/6/2015




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