Back to FDA Applications sponsored by ACTAVIS LABS UT INC

FDA Drug Application 204571 by ACTAVIS LABS UT INC

Application Number204571
Application Type Abbreviated New Drug Application
Sponsor ApplicantACTAVIS LABS UT INC
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
TA02/24/2015TA43596000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204571Orig1s000ltr.pdf 8/10/2015
TA02/24/2015TA43649000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?REMS=349&event=IndvRemsDetails.page&source=govdelivery&utm_medium=email&utm_source=govdelivery 8/14/2015
AP18/5/2015N43596000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204571Orig1s000ltr.pdf 8/10/2015
AP18/5/2015N43649000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?REMS=349&event=IndvRemsDetails.page&source=govdelivery&utm_medium=email&utm_source=govdelivery 8/14/2015




Back to FDA Applications sponsored by ACTAVIS LABS UT INC