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FDA Drug Application 020819 by ABBVIE

Application Number020819
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/17/1998N2041000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20819_Zemplar.cfm 4/17/1998
AP04/17/1998N315000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20819ltr.pdf 4/17/1998
AP04/17/1998N316000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20819lbl.pdf 4/17/1998
AP02/2/2000SE81302003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20819S3LTR.PDF 2/2/2000
AP02/2/2000SE81303003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20819S3LBL.PDF 2/2/2000
AP09/13/2000SLR       
AP010/18/1999SCS       
AP02/1/2000SCF       
AP02/24/2003SLR4271007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf 3/10/2003
AP01/8/2002SCE       
AP01/25/2002SCM       
AP02/24/2003SLR4272011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf 3/10/2003
AP012/6/2002SCS       
AP03/31/2004SE58245014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20819se5-014_zemplar_lbl.pdf 4/5/2004
AP03/31/2004SE58305014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20819se5-014ltr.pdf 4/7/2004
AP09/2/2005SLR12743015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020819s015lbl.pdf 9/8/2005
AP09/2/2005SLR12744015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020819s015ltr.pdf 9/8/2005
AP08/20/2009SLR23399021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020819s021lbl.pdf 9/17/2009
AP08/20/2009SLR23988021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020819s021ltr.pdf 11/19/2009
AP02/1/2011SLR27722024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s024ltr.pdf 2/4/2011
AP04/6/2011SLR28487025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020819s025lbl.pdf 4/7/2011
AP04/6/2011SLR28492025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s025ltr.pdf 4/11/2011
AP07/22/2013SCM       




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