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FDA Drug Application 021268 by ABBVIE

Application Number021268
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/1/2001N3935000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_Approv.pdf 11/1/2001
AP011/1/2001N3936000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf 11/1/2001
AP011/1/2001N3937000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_Teveten.cfm 3/5/2002
AP011/1/2001N31212000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP09/27/2002SCM       
AP010/16/2003SLR6823002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf 10/17/2003
AP07/7/2003SCM6124006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21268scm006ltr.pdf 7/10/2003
AP07/11/2005SCS12001009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021268s009ltr.pdf 7/15/2005
AP05/19/2011SLR28890015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf 5/23/2011
AP05/19/2011SLR28923015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf 5/25/2011
AP05/19/2011SLR28891016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf 5/23/2011
AP05/19/2011SLR28924016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf 5/25/2011
AP01/19/2012SLR31446017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf 1/23/2012
AP01/19/2012SLR31448017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf 1/23/2012
AP09/12/2012SLR33745018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021268Orig1s018ltr.pdf 9/14/2012
AP09/12/2012SLR33761018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf 9/14/2012
AP07/22/2014SLR39963019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021268Orig1s019ltr.pdf 7/24/2014
AP07/22/2014SLR39972019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf 7/24/2014




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