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FDA Drug Application 021222 by VANSEN PHARMA

Application Number021222
Application Type New Drug Application
Sponsor ApplicantVANSEN PHARMA
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
AP08/29/2001N3286000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21222ltr.pdf 8/29/2001
AP08/29/2001N3287000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21222lbl.pdf 8/29/2001
AP08/29/2001N3288000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-222_Spectracef.cfm 12/7/2001
AP08/21/2002SE13284001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21222se1-001ltr.pdf 8/26/2002
AP08/21/2002SE13285001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21222s1lbl.pdf 8/21/2002
AP06/11/2002SCE       
AP03/23/2004SLR8117003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21222s003ltr.pdf 3/28/2004
AP09/23/2009SLR23825006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021222s006ltr.pdf 11/12/2009
AP012/20/2005SLR13344009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021222s009lbl.pdf 1/6/2006
AP012/20/2005SLR13402009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021222s009ltr.pdf 1/19/2006
AP07/21/2008SCF20281012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021222s012lbl.pdf 7/23/2008
AP07/21/2008SCF20500012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021222s012ltr.pdf 8/5/2008
AP08/6/2012SLR33403013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021222Orig1s013,s016ltr.pdf 8/7/2012
AP08/6/2012SLR33407013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf 8/7/2012
AP08/6/2012SLR33404016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021222Orig1s013,s016ltr.pdf 8/7/2012
AP08/6/2012SLR33408016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf 8/7/2012




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