Back to FDA Applications sponsored by SCHERING

FDA Drug Application 020718 by SCHERING

Application Number020718
Application Type New Drug Application
Sponsor ApplicantSCHERING
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
AP05/18/1998N1903000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20718_Integrilin.cfm 5/18/1998
AP05/18/1998N152000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20718ltr.pdf 5/18/1998
AP05/18/1998N153000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20718lbl.pdf 5/18/1998
AP09/11/1998SLR       
AP09/20/1999SE81090002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20718s02ltr.pdf 9/20/1999
AP09/20/1999SE81091002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20718s02lbl.pdf 9/20/1999
AP09/20/1999SE81904002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20718S002_Integrilin.cfm 9/20/1999
AP07/21/1999SLR       
AP07/21/1999SCS       
AP04/16/1999SCM       
AP012/3/1999SCM       
AP03/3/2000SCS       
AP06/26/2000SCM       
AP05/31/2000SCS       
AP06/8/2001SE21905010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf 6/8/2001
AP06/8/2001SE21906010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf 6/8/2001
AP06/8/2001SE21907010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-718_Integrilin.cfm 6/8/2001
AP07/3/2001SCM       
AP06/8/2001SLR1908013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf 6/8/2001
AP06/8/2001SLR1909013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf 6/8/2001
AP06/8/2001SLR1910013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-718_Integrilin.cfm 6/8/2001
AP07/26/2001SCM       
AP01/10/2002SCS       
AP02/14/2002SCM       
AP06/16/2003SE85963017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20718se8-017ltr.pdf 6/22/2003
AP06/16/2003SE85997017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20718se8-017_integrilin_lbl.pdf 6/22/2003
AP07/15/2004SLR9772022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20718s022ltr.pdf 7/21/2004
AP010/12/2005SLR12871025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020718s025ltr.pdf 10/14/2005
AP010/12/2005SLR12881025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020718s025lbl.pdf 10/14/2005
AP012/15/2008SLR21370028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020718s028ltr.pdf 12/19/2008
AP012/15/2008SLR21471028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020718s028lbl.pdf 1/2/2009
AP03/30/2011SLR28434034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020718s034lbl.pdf 4/1/2011
AP03/30/2011SLR28440034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020718s034ltr.pdf 4/4/2011
AP03/25/2013SLR35511037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020718s037lbl.pdf 3/25/2013
AP03/25/2013SLR35546037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020718Orig1s037ltr.pdf 3/26/2013




Back to FDA Applications sponsored by SCHERING