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FDA Drug Application 021695 by LUPIN ATLANTIS

Application Number021695
Application Type New Drug Application
Sponsor ApplicantLUPIN ATLANTIS
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
AP011/30/2004N10725000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021695lbl.pdf 12/3/2004
AP011/30/2004N10735000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021695ltr.pdf 12/6/2004
AP011/30/2004N14258000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021695s000_AntaraTOC.cfm 6/8/2006
AP010/21/2005S15693001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021695s001ltr.pdf 1/23/2007
AP06/3/2008SLR19963006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021695s006ltr.pdf 6/6/2008
AP06/3/2008SLR20033006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf 6/19/2008
AP03/1/2012SLR32028008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695s008ltr.pdf 3/5/2012
AP03/1/2012SLR32044008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s008lbl.pdf 3/6/2012
AP010/18/2013SCM37492009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021695Orig1s009ltr.pdf 10/22/2013
AP010/18/2013SCM37522009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021695s009lbl.pdf 10/22/2013
AP012/19/2012SLR34742010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s010lbl.pdf 12/21/2012
AP012/19/2012SLR34753010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695Orig1s010ltr.pdf 12/26/2012
AP09/4/2014SCM       
AP08/31/2015SCM43808012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021695s012lbl.pdf 9/4/2015




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