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FDA Drug Application 021149 by EMD SERONO

Application Number021149
Application Type New Drug Application
Sponsor ApplicantEMD SERONO
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
AP09/20/2000N10740000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-149_Ovidrel.cfm 12/7/2004
AP09/20/2000N1312000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf 9/20/2000
AP09/20/2000N1313000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf 9/20/2000
AP05/15/2002SCS       
AP07/14/2003SLR6157006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf 7/28/2003
AP07/30/2007SLR17427013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf 7/31/2007
AP07/30/2007SLR17433013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf 7/31/2007
AP07/9/2013SCM       
AP06/2/2010SLR25710020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf 6/7/2010
AP06/2/2010SLR25716020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf 6/8/2010
AP012/13/2012SCM       
AP012/10/2012SCM       
AP01/15/2013SCM       
AP01/31/2013SCM       
AP01/15/2013SCM       
AP02/8/2013SCM       
AP01/31/2013SCM       
AP04/5/2013SCM       
AP04/11/2013SCM       
AP012/11/2013SCM       
AP012/19/2013SCM       
AP012/11/2014SCM       
AP09/30/2015SCM       




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