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FDA Drug Application 020943 by RECRO GAINESVILLE

Application Number020943
Application Type New Drug Application
Sponsor ApplicantRECRO GAINESVILLE
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
AP011/25/1998N669000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20943ltr.pdf 11/25/1998
AP011/25/1998N670000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20943lbl.pdf 11/25/1998
AP011/25/1998N2383000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-943_VerelanPM.cfm 11/25/1998
AP07/2/1999SCM       
AP06/4/1999SLR       
AP012/13/1999SCM       
AP07/27/2000SCM       
AP011/29/2000SCM       
AP04/1/2010SLR25249007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf 4/9/2010
AP04/1/2010SLR25402007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf 4/30/2010
AP012/26/2002SCS       
AP05/5/2004SLR8535013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20943slr013_verapamil_lbl.pdf 5/7/2004
AP05/5/2004SLR8544013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20943slr013ltr.pdf 5/7/2004
AP05/1/2007SLR16432020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020943s020ltr.pdf 5/7/2007
AP012/16/2009SLR24300021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020943s021lbl.pdf 12/17/2009
AP012/16/2009SLR24339021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020943s021ltr.pdf 12/24/2009
AP04/1/2010SLR25190026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf 4/4/2010
AP04/1/2010SLR25212026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf 4/5/2010
AP011/14/2011SLR30577028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020943s028lbl.pdf 11/14/2011
AP011/14/2011SLR30597028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020943s028ltr.pdf 11/16/2011
AP010/14/2014SLR40760029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020943Orig1s029ltr.pdf 10/14/2014
AP010/14/2014SLR40787029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020943s029lbl.pdf 10/15/2014




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