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FDA Drug Application 021732 by ENDO PHARM

Application Number021732
Application Type New Drug Application
Sponsor ApplicantENDO PHARM
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
AP010/12/2004N10411000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21732ltr.pdf 10/15/2004
AP010/12/2004N10422000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21732lbl.pdf 10/15/2004
AP010/12/2004N14427000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021732s000_VantasTOC.cfm 7/5/2006
AP02/4/2011SLR27774007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf 2/9/2011
AP02/4/2011SLR27808007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf 2/10/2011
AP02/4/2011SLR27775010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf 2/9/2011
AP02/4/2011SLR27809010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf 2/10/2011
AP02/4/2011SLR27776012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf 2/9/2011
AP02/4/2011SLR27810012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf 2/10/2011
AP01/14/2011SLR27552013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s013ltr.pdf 1/20/2011
AP01/14/2011SLR27572013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s013lbl.pdf 1/20/2011
AP01/9/2014SCM38251015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021732s015lbl.pdf 1/10/2014
AP04/4/2013SLR35655018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021732s018lbl.pdf 4/9/2013
AP04/4/2013SLR35664018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021732Orig1s018ltr.pdf 4/9/2013
AP07/8/2014SLR39824019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021732Orig1s019ltr.pdf 7/10/2014
AP07/31/2015SCM       




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