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FDA Drug Application 021991 by MERCK

Application Number021991
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/6/2006N15082000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021991lbl.pdf 10/11/2006
AP010/6/2006N15090000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021991s000ltr.pdf 10/13/2006
AP010/6/2006N15372000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021991s000_ZolinzaTOC.cfm 11/20/2006
AP07/22/2008SLR20282001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021991s001lbl.pdf 7/23/2008
AP07/22/2008SLR20289001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021991s001ltr.pdf 7/24/2008
AP011/14/2011SLR30573002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021991s002lbl.pdf 11/15/2011
AP011/14/2011SLR30649002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021991s002ltr.pdf 11/17/2011
AP09/23/2009SE823507004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021991s004lbl.pdf 10/1/2009
AP09/23/2009SE823780004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021991s004ltr.pdf 11/10/2009
AP06/10/2011SLR29225005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP010/7/2015SCM       
AP012/17/2015SLR44852008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021991Orig1s008ltr.pdf 12/22/2015




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