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FDA Drug Application 020509 by LILLY

Application Number020509
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/15/1996N       
AP02/5/1997SCM       
AP04/11/1997SCS       
AP010/10/1997SCM       
AP09/18/1997SLR       
AP08/25/1998SE1562005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20509ltr.pdf 8/25/1998
AP08/25/1998SE1563005   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20509lbl.pdf 8/25/1998
AP01/23/1998SCM       
AP010/16/1998SCS       
AP06/23/2000SLR       
AP011/23/1998SCM       
AP01/6/2003SLR4213013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf 3/7/2003
AP01/6/2003SLR11355013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20509slr013ltr.pdf 4/7/2005
AP03/3/2000SCS       
AP06/22/2000SCS       
AP06/9/2000SCS       
AP01/4/2001SCS       
AP011/1/2000SCS       
AP05/18/2001SCS       
AP05/1/2002SCS2109021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20509s021ltr.pdf 5/1/2002
AP011/13/2002SCS       
AP05/19/2004SE18570029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf 5/19/2004
AP05/19/2004SE18657029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20509se1-029ltr.pdf 5/26/2004
AP05/19/2004SE118541029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020509_S029_GEMZAR_AP.pdf 11/19/2007
AP04/20/2005SLR11496032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s032ltr.pdf 4/28/2005
AP04/20/2005SLR11516032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s032lbl.pdf 4/28/2005
AP04/26/2005SE811531033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s033ltr.pdf 4/28/2005
AP04/26/2005SE811537033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf 4/28/2005
AP04/26/2005SE819161033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020509_S033_GEMZAR.pdf 2/19/2008
AP04/5/2006SLR13874037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s037ltr.pdf 4/7/2006
AP07/14/2006SE114502039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s039_ltr.pdf 7/21/2006
AP03/19/2010SLR25096064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020509s064ltr.pdf 3/24/2010
AP03/19/2010SLR25127064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf 3/26/2010
AP02/4/2011SLR27777069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf 2/9/2011
AP05/7/2013SLR35986072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020509s072lbl.pdf 5/8/2013
AP06/10/2014SLR39519075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s075ltr.pdf 6/12/2014
AP06/10/2014SLR44195075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf 10/13/2015
AP08/11/2014SCM       
AP05/8/2014SLR39269077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s077lbl.pdf 5/12/2014
AP05/8/2014SLR39285077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s077ltr.pdf 5/12/2014




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