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FDA Drug Application 017821 by JANSSEN RES AND DEV

Application Number017821
Application Type New Drug Application
Sponsor ApplicantJANSSEN RES AND DEV
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/26/1977N       
AP03/14/1978SLR       
AP03/2/1978SLR       
AP05/3/1979SCM       
AP05/31/1979SLR       
AP08/21/1980SCS       
AP010/10/1980SLR       
AP010/10/1980SCM       
AP010/10/1980SCF       
AP012/2/1980SCP       
AP06/3/1982SLR       
AP05/26/1981SCM       
AP05/26/1981SCP       
AP06/21/1983SCP       
AP04/1/1982SCM       
AP05/13/1982SCS       
AP01/4/1983SCP       
AP06/21/1997SLR       
AP02/24/1984SCM       
AP01/16/1986SLR       
AP05/30/1986SLR       
AP04/8/1988SCP       
AP06/9/1994SCM       
AP01/10/1990SCM       
AP08/18/1994SCS       
AP03/1/1996SCM       
AP011/29/1996SCS       
AP09/15/1998SCS       
AP02/3/2003SE84151045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017821s045lbl.pdf 3/5/2003
AP02/3/2003SE89003045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17821se8-045ltr.pdf 6/4/2004
AP02/3/2003SE819590045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017821_S045_FLEXERIL.pdf 4/2/2008
AP010/3/2002SCM       
AP011/5/2002SCM       
AP04/11/2013SLR35692051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017821Orig1s051ltr.pdf 4/16/2013
AP04/11/2013SLR35732051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017821s051lbl.pdf 4/16/2013




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