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FDA Drug Application 018066 by CHATTEM

Application Number018066
Application Type New Drug Application
Sponsor ApplicantCHATTEM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/18/1978N       
AP02/13/1978SCP       
AP08/31/1981SCE       
AP012/21/1981SCS       
AP08/5/1982SCE       
AP08/5/1982SCE       
AP08/12/1987SCE       
AP03/11/1983SCP       
AP02/23/1984SCS       
AP05/30/1989SCF       
AP08/24/1984SCS       
AP05/30/2002SLR4868011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18066s011ltr.pdf 5/30/2002
AP04/26/2002SCM       
AP05/30/2002SLR1991013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18066s011ltr.pdf 5/30/2002
AP012/20/2002SCM       
AP09/12/2013SLR37079020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018066Orig1s020ltr.pdf 9/13/2013
AP09/12/2013SLR37218020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018066Orig1s020lbl.pdf 9/24/2013




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