Back to FDA Applications sponsored by FRESENIUS KABI USA

FDA Drug Application 020533 by FRESENIUS KABI USA

Application Number020533
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
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
AP09/24/1996N       
AP05/1/1998SCP       
AP011/2/2000SE29588002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-533s002_Naropin.cfm 6/28/2004
AP06/22/2000SLR       
AP02/9/2000SCS       
AP011/14/2000SCM       
AP07/17/2002SCS       
AP08/11/2004SLR10005012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20533s012ltr.pdf 8/12/2004
AP08/11/2004SLR10018012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf 8/12/2004
AP08/8/2006SLR14643014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020533s014lbl.pdf 8/9/2006
AP08/8/2006SLR14673014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020533s014LTR.pdf 8/11/2006
AP02/19/2010SLR24846020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf 2/25/2010
AP02/19/2010SLR24856020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf 2/25/2010
AP02/19/2010SLR24847021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf 2/25/2010
AP02/19/2010SLR24857021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf 2/25/2010
AP04/21/2013SCM       
AP010/29/2014SCM40906026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020533Orig1s026ltr.pdf 10/30/2014
AP011/15/2012SCM       
AP012/26/2012SCM34847028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s028lbl.pdf 1/7/2013
AP011/9/2012SCM34394029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s029lbl.pdf 11/15/2012
AP02/16/2013SCM       
AP06/6/2016SCM       




Back to FDA Applications sponsored by FRESENIUS KABI USA