Back to FDA Applications sponsored by APIL

FDA Drug Application 020835 by APIL

Application Number020835
Application Type New Drug Application
Sponsor ApplicantAPIL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/27/1998N2453000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.htm 3/27/1998
AP03/27/1998N7072000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 12/8/2003
AP03/27/1998N8580000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.cfm 5/25/2004
AP03/27/1998N27645000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241447.pdf 2/1/2011
AP04/14/2000SE14699001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf 4/14/2000
AP04/14/2000SE14700001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm 8/17/2001
AP04/14/2000SE11164001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf 4/14/2000
AP04/14/2000SE11165002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf 4/14/2000
AP04/14/2000SE14701002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf 4/14/2000
AP04/14/2000SE14706002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm 8/17/2001
AP04/14/2000SE14702003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf 4/14/2000
AP04/14/2000SE11166003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf 4/14/2000
AP04/14/2000SE14705003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm 8/17/2001
AP04/14/2000SE11417004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf 4/14/2000
AP04/14/2000SE14703004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf 4/14/2000
AP04/14/2000SE14704004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm 8/17/2001
AP05/2/2001SCS       
AP012/21/2001SCS       
AP05/17/2002SE22451008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf 5/17/2002
AP05/17/2002SE25647008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020835s008lbl.pdf 5/20/2003
AP05/17/2002SE22452009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf 5/17/2002
AP09/26/2002SCS19163010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S010_ACTENOL.pdf 2/19/2008
AP011/5/2002SCP19164011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S011_ACTONEL.pdf 2/19/2008
AP012/10/2002SCM19165012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S012_ACTONEL.pdf 2/19/2008
AP02/24/2004SLR7719014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20835slr014ltr.pdf 2/25/2004
AP02/24/2004SLR8201014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf 4/5/2004
AP02/24/2004SLR17405014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020835_S014_ACTONEL TABLETS.pdf 7/27/2007
AP05/6/2005SLR11611018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s018ltr.pdf 5/17/2005
AP05/6/2005SLR11639018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s018lbl.pdf 5/17/2005
AP01/24/2006SE813483019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf 1/25/2006
AP01/24/2006SE813544019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf 1/30/2006
AP09/12/2005SLR12787020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s020ltr.pdf 9/15/2005
AP09/12/2005SLR12799020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s020lbl.pdf 9/15/2005
AP08/11/2006SE114682022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf 8/14/2006
AP08/11/2006SE114738022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf 8/21/2006
AP08/11/2006SLR14739023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf 8/21/2006
AP08/11/2006SLR14683023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf 8/14/2006
AP04/16/2007SE216231025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s025ltr.pdf 4/20/2007
AP04/16/2007SE216267025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf 4/20/2007
AP07/24/2007SLR17383028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf 7/27/2007
AP07/24/2007SLR17388028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s028ltr.pdf 7/27/2007
AP04/22/2008SLR19723029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf 4/25/2008
AP04/22/2008SE219724030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf 4/25/2008
AP07/23/2009SE823094035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf 7/30/2009
AP07/23/2009SE823103035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s035ltr.pdf 7/31/2009
AP012/31/2009SLR24405036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf 1/4/2010
AP012/31/2009SLR24445036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s036ltr.pdf 1/6/2010
AP01/25/2011SLR27634042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf 1/31/2011
AP01/25/2011SLR27671042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf 2/2/2011
AP01/25/2011SLR27672043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf 2/2/2011
AP01/25/2011SLR27635043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf 1/31/2011
AP08/22/2011SLR29845044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s044ltr.pdf 8/24/2011
AP04/19/2013SLR35773045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020835Orig1s045ltr.pdf 4/23/2013
AP04/19/2013SLR35808045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf 4/23/2013
AP012/2/2014SCM       
AP03/26/2015SLR42307047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s047ltr.pdf 3/27/2015
AP03/26/2015SLR42316047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf 3/27/2015
AP04/8/2015SLR42491048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf 4/10/2015
AP04/8/2015SLR42503048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s048ltr.pdf 4/13/2015
AP010/22/2015SCM       




Back to FDA Applications sponsored by APIL