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FDA Drug Application 020668 by ASTRAZENECA

Application Number020668
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP012/27/1996N       
AP07/2/1997SCM17133001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020668_S001_Lexxel Tablets.pdf 7/6/2007
AP03/3/1998SLR17134002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020668_S002_Lexxel Tablets.pdf 7/6/2007
AP010/28/1998SCS2882003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_Approv.pdf 10/28/1998
AP010/28/1998SCS2883003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_prntlbl.pdf 10/28/1998
AP010/28/1998SCS2884003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668s003_Lexxel.cfm 7/25/2002
AP07/22/1998SLR19204004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020668_S004_LEXXEL.pdf 2/19/2008
AP08/2/2005SLR12535005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020668s005lbl.pdf 8/4/2005
AP08/2/2005SLR12540005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020668s005ltr.pdf 8/4/2005
AP07/18/2000SLR       
AP02/6/2001SCS       
AP09/18/2001SLR       
AP06/11/2003SLR5961009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20668slr009ltr.pdf 6/22/2003
AP06/7/2004SLR9309011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20668slr011ltr.pdf 6/10/2004
AP06/7/2004SLR9316011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20668slr011_lexxel_lbl.pdf 6/10/2004
AP012/23/2004SLR10817012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20668s012ltr.pdf 12/29/2004
AP010/4/2007SLR18203013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020668s013ltr.pdf 10/10/2007




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