Back to FDA Applications sponsored by MYLAN

FDA Drug Application 075417 by MYLAN

Application Number075417
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN
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
AP05/27/1999N974000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75417ltr.pdf 5/27/1999
AP05/27/1999N6339000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075417_clozapine_toc.cfm 8/4/2003
AP05/27/1999N43879000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 9/16/2015
AP03/12/2001SL       
AP04/15/2010SE225353021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf 4/28/2010
AP04/15/2010SE225354024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf 4/28/2010
AP04/15/2010SLR25352025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf 4/28/2010




Back to FDA Applications sponsored by MYLAN