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FDA Drug Application 021642 by ENDO PHARMS INC

Application Number021642
Application Type New Drug Application
Sponsor ApplicantENDO 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
AP01/31/2005N11074000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021642ltr.pdf 2/3/2005
AP01/31/2005N11080000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf 2/3/2005
AP01/31/2005N14316000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021642s000_NascobalTOC.cfm 6/16/2006
AP09/15/2006SLR14837002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021642s002lbl.pdf 9/18/2006
AP09/15/2006SLR14909002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021642s002ltr.pdf 9/20/2006
AP06/11/2014SLR       
AP012/8/2011SCM38472015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021642Orig1s015ltr.pdf 2/7/2014
AP012/8/2011SCM38473015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf 2/7/2014
AP011/15/2012SCM       
AP16/6/2014SLR39487020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf 6/10/2014
AP09/6/2013SCM       
AP010/30/2014SCM       
AP06/17/2015SCM       
AP04/25/2016SCM       




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