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FDA Drug Application 079046 by ACTAVIS ELIZABETH

Application Number079046
Application Type Abbreviated New Drug Application
Sponsor ApplicantACTAVIS ELIZABETH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/13/2010N27327000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf 12/22/2010
AP012/13/2010N27328000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf 12/22/2010
AP012/13/2010N36553000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf 7/12/2013
AP012/13/2010N43142000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
TA112/13/2010TA27327000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf 12/22/2010
TA112/13/2010TA27328000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf 12/22/2010
TA112/13/2010TA36553000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf 7/12/2013
TA112/13/2010TA43142000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP27/11/2013N27327000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf 12/22/2010
AP27/11/2013N27328000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf 12/22/2010
AP27/11/2013N36553000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf 7/12/2013
AP27/11/2013N43142000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP04/16/2014SLR39239013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/079046Orig1s013lbl.pdf 5/6/2014




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