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FDA Drug Application 019834 by ASTRAZENECA

Application Number019834
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP07/25/1991N       
AP09/22/1993SLR       
AP09/22/1994SE26443002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019834S002_plendil_toc.cfm 8/7/2003
AP07/14/1995SLR19581004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019834_S004_PLENDIL.pdf 4/2/2008
AP02/5/1996SCP20575005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019834_s005_PLENDIL.pdf 8/11/2008
AP07/3/1996SCS20574006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019834_s006_PLENDIL.pdf 8/11/2008
AP07/29/1996SCS20534007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019834_s007_PLENDIL.pdf 8/8/2008
AP012/12/1996SCS       
AP01/13/1998SLR6442009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019834S009_plendil_toc.cfm 8/7/2003
AP01/13/1998SLR9334009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_APPROV.PDF 6/14/2004
AP01/13/1998SLR9335009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_PRNTLBL.PDF 6/14/2004
AP010/23/1997SCP       
AP08/7/1997SCM20564012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019834_s012_PLENDIL.pdf 8/11/2008
AP07/14/1998SLR20547013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019834_s013.pdf 8/8/2008
AP02/8/2000SLR20492014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019834_s014_PLENDIL.pdf 8/4/2008
AP08/28/2000SLR       
AP011/23/1999SCM20535016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019834_016_PLENDIL.pdf 8/8/2008
AP05/22/2002SLR20451017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_017_PLENDIL.pdf 8/4/2008
AP05/22/2002SLR3552017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19834S017ltr.pdf 5/22/2002
AP05/22/2002SLR3553017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19834s17lbl.pdf 5/22/2002
AP09/26/2002SCS20455019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_S019_PLENDIL.pdf 8/4/2008
AP08/26/2002SCM19582020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_S020_PLENDIL.pdf 4/2/2008
AP06/7/2004SLR19583022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019834_S022_PLENDIL.pdf 4/2/2008
AP06/7/2004SLR9310022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19834slr022ltr.pdf 6/10/2004
AP06/7/2004SLR9315022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19834slr022_plendil_lbl.pdf 6/10/2004
AP010/31/2012SLR34221025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf 11/2/2012
AP010/31/2012SLR34244025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019834Orig1s025ltr.pdf 11/5/2012




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