Back to FDA Applications sponsored by HOFFMANN LA ROCHE

FDA Drug Application 021304 by HOFFMANN LA ROCHE

Application Number021304
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/29/2001N1590000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21304ltr.pdf 3/29/2001
AP03/29/2001N1591000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf 3/29/2001
AP03/29/2001N8326000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21304_Valcyte.cfm 4/12/2004
AP09/12/2003SE16659001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21304se1-001ltr.pdf 9/25/2003
AP09/12/2003SE16675001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf 9/25/2003
AP09/12/2003SE118502001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021304_S001_VALCYTE.pdf 11/19/2007
AP01/31/2006SLR13575004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021304s004lbl.pdf 2/2/2006
AP01/31/2006SLR13581004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021304s004ltr.pdf 2/2/2006
AP08/28/2009SLR23257007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf 8/30/2009
AP08/28/2009SLR23266007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf 9/1/2009
AP08/28/2009SLR25632007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_valganciclovir hydrochloride_toc.cfm 5/27/2010
AP08/28/2009SLR25633007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-1_021304s007sumr.pdf 5/27/2010
AP08/5/2010SE226160008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003ltr.pdf 8/10/2010
AP08/5/2010SE226173008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf 8/10/2010
AP03/28/2013SLR35582010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021304Orig1s010,022257Orig1s004ltr.pdf 4/1/2013
AP03/28/2013SLR35619010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf 4/1/2013
AP04/23/2015SE842647011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf 4/24/2015
AP04/23/2015SE842676011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf 4/28/2015




Back to FDA Applications sponsored by HOFFMANN LA ROCHE