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FDA Drug Application 017831 by APIL

Application Number017831
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/1/1977N18698000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP01/11/1978SLR       
AP01/23/1979SES       
AP01/23/1979SCS       
AP01/23/1979SCS       
AP01/23/1979SCS       
AP08/25/1980SES       
AP012/13/1979SCM       
AP05/14/1980SLR       
AP010/1/1980SCP       
AP08/4/1981SLR       
AP09/8/1982SLR       
AP08/25/1982SCS       
AP01/11/1983SLR       
AP01/11/1983SCS       
AP01/8/1983SCS       
AP07/6/1984SCS       
AP07/6/1984SLR       
AP01/7/1986SCS       
AP01/7/1986SCS       
AP07/10/1986SCS       
AP03/24/1986SLR       
AP07/10/1986SCS       
AP03/1/1988SLR       
AP09/23/1988SLR       
AP08/2/1988SLR       
AP07/5/1989SLR       
AP06/7/1993SLR       
AP09/28/1993SCS       
AP05/5/1994SLR       
AP02/27/1996SLR       
AP02/29/1996SLR       
AP010/4/1996SLR       
AP06/16/1997SLR       
AP03/15/2002SLR1683052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17831s52ltr.pdf 3/15/2002
AP02/25/2004SLR7744053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17831slr053ltr.pdf 2/27/2004
AP02/25/2004SLR8186053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17831slr053_didronel_lbl.pdf 4/5/2004
AP02/25/2004SLR17039053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/017831_S053_DIDRONEL_AP.pdf 7/6/2007
AP01/9/2006SLR13372054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017831s054lbl.pdf 1/10/2006
AP01/9/2006SLR13436054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017831s054ltr.pdf 1/20/2006
AP012/31/2009SLR24406055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017831s055lbl.pdf 1/4/2010
AP012/31/2009SLR24443055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017831s055ltr.pdf 1/6/2010
AP04/19/2013SLR35810056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017831s056lbl.pdf 4/23/2013
AP04/19/2013SLR35814056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017831Orig1s056ltr.pdf 4/24/2013
AP03/18/2015SLR42208057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s057lbl.pdf 3/19/2015
AP03/18/2015SLR42210057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s057ltr.pdf 3/19/2015
AP04/8/2015SLR42486058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s058lbl.pdf 4/10/2015
AP04/8/2015SLR42495058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s058ltr.pdf 4/13/2015




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