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FDA Drug Application 018956 by GE HEALTHCARE

Application Number018956
Application Type New Drug Application
Sponsor ApplicantGE HEALTHCARE
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
AP012/26/1985N       
AP011/26/1986SE1       
AP02/5/1987SCM       
AP011/20/1986SLR       
AP04/21/1987SLR       
AP05/27/1987SLR       
AP06/4/1987SCP       
AP012/23/1993SCM       
AP05/12/1987SE1       
AP05/22/1989SCM       
AP02/1/1988SE5       
AP01/27/1988SCS       
AP07/29/1988SE1       
AP05/24/1988SE1       
AP04/18/1988SCM       
AP011/30/1988SE1       
AP03/31/1989SE1       
AP01/4/1989SCS       
AP06/30/1989SE1       
AP06/30/1989SE1       
AP07/28/1989SE5       
AP07/28/1989SE1       
AP05/3/1989SLR       
AP011/30/1989SE5       
AP03/26/1992SCS       
AP07/13/1993SE36354028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018956-S28_Omnipaque_toc.cfm 8/5/2003
AP08/24/1990SCP       
AP012/4/1995SCS       
AP03/1/1993SCM       
AP03/1/1993SCS       
AP03/1/1993SLR       
AP03/1/1993SCP       
AP06/1/1994SCP       
AP06/1/1994SLR       
AP012/11/1992SCP       
AP09/30/1992SCM       
AP012/23/2002SLR3492039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr039ltr.pdf 12/23/2002
AP010/20/1992SCS       
AP09/30/1994SCP       
AP011/28/1995SCS       
AP06/15/1995SLR3756043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18956a_s043_061595.pdf 5/11/1998
AP08/18/1995SCS       
AP011/4/1994SCM       
AP08/18/1995SCM       
AP012/23/2002SLR3491049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr049ltr.pdf 12/23/2002
AP09/8/1998SCS       
AP012/19/2000SCS       
AP08/5/2002SCM       
AP011/20/2002SCM       
AP03/5/2004SLR7865058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956slr058ltr.pdf 3/10/2004
AP012/27/2004SLR10816062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956s062ltr.pdf 12/29/2004
AP03/25/2005SCM11324065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18956s065ltr.pdf 3/30/2005
AP010/1/2007SLR18129076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018956s076ltr.pdf 10/4/2007
AP08/21/2013SCM       
AP02/10/2014SCM       
AP011/20/2013SCM       
AP06/19/2014SCM       
AP03/3/2015SCM       
AP07/6/2015SLR43291095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf 7/9/2015
AP07/6/2015SLR43305095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018956Orig1s095,020608Orig1s031ltr.pdf 7/10/2015
AP010/21/2015SCM       




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