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FDA Drug Application 050740 by ASTELLAS

Application Number050740
Application Type New Drug Application
Sponsor ApplicantASTELLAS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/11/1997N22776000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050740_ambisome_toc.cfm 6/19/2009
AP01/28/2000SE84377001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_Approv.pdf 1/28/2000
AP01/28/2000SE84378001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_prntlbl.pdf 1/28/2000
AP01/28/2000SE86268001   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/050740s001_ambisome_toc.cfm 7/31/2003
AP06/16/2000SE18711002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S2_AmBisome.cfm 5/27/2004
AP06/16/2000SE14379002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50740S2LTR.PDF 7/18/2000
AP06/16/2000SE14380002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50740S2LBL.PDF 7/18/2000
AP03/16/2000SCM       
AP02/29/2000SCM       
AP06/26/2000SCM       
AP07/13/2000SCP       
AP05/11/2001SCS       
AP012/4/2001SCS       
AP03/6/2002SCM       
AP03/27/2002SCS       
AP06/14/2002SCM       
AP09/6/2002SCS       
AP09/16/2003SLR6673014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50740slr014ltr.pdf 9/25/2003
AP09/16/2003SLR6696014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50740slr014_ambisome_lbl.pdf 9/26/2003
AP010/8/2008SLR21024016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050740s016ltr.pdf 10/14/2008
AP010/8/2008SLR21200016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050740s016lbl.pdf 11/7/2008
AP03/8/2012SLR32079021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf 3/9/2012
AP03/8/2012SLR32095021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050740s021ltr.pdf 3/13/2012
AP09/16/2014SCM       
AP09/23/2016SCM       




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