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FDA Drug Application 020738 by ABBVIE

Application Number020738
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
AP012/22/1997N28740000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020738_tevetan_toc.cfm 5/6/2011
AP012/22/1997N31211000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP010/28/1998SE26418001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020738s001_teveten_toc.cfm 8/7/2003
AP010/28/1998SE29446001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_APPROV.PDF 6/18/2004
AP010/28/1998SE29447001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_PRNTLBL.PDF 6/18/2004
AP06/30/1998SCP       
AP05/21/1998SCM       
AP05/27/1999SCF3938004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20738-s004_teveten.pdf 7/5/2001
AP012/2/1999SCM       
AP010/4/1999SCM       
AP011/5/1999SCM       
AP05/8/2000SCM       
AP012/15/2000SCM       
AP010/29/2001SCM       
AP010/16/2003SLR6822012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf 10/17/2003
AP05/3/2011SLR28708026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020738s026lbl.pdf 5/5/2011
AP05/3/2011SLR28730026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020738s026ltr.pdf 5/6/2011
AP01/19/2012SLR31445027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s027lbl.pdf 1/23/2012
AP01/19/2012SLR31447027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf 1/23/2012
AP09/12/2012SLR33744028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738Orig1s028ltr.pdf 9/14/2012
AP09/12/2012SLR33762028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s028lbl.pdf 9/14/2012
AP07/22/2014SLR39962029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020738Orig1s029ltr.pdf 7/24/2014
AP07/22/2014SLR39973029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020738s029lbl.pdf 7/24/2014




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