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FDA Drug Application 021006 by ENDO PHARMS

Application Number021006
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/8/2001N2183000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_Approv.pdf 11/8/2001
AP011/8/2001N2185000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_prntlbl.pdf 11/8/2001
AP011/8/2001N2186000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova.cfm 11/8/2001
AP011/8/2001N7117000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 12/9/2003
AP03/3/2009SLR21951006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf 3/5/2009
AP03/3/2009SLR22165006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf 4/3/2009
AP03/3/2009SLR21952009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf 3/5/2009
AP03/3/2009SLR22307009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf 4/23/2009
AP03/3/2009SLR21953010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf 3/5/2009
AP03/3/2009SLR22166010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf 4/3/2009
AP09/30/2014SCM       
AP010/11/2013SLR37416019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021006Orig1s019ltr.pdf 10/15/2013
AP010/11/2013SLR37434019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021006s019lbl.pdf 10/17/2013
AP09/27/2013SCM       




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