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FDA Drug Application 020599 by COVIS PHARMA SARL

Application Number020599
Application Type New Drug Application
Sponsor ApplicantCOVIS PHARMA SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/12/1995N       
AP011/4/1996SCS       
AP05/19/2003SLR43418002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s002.pdf 7/20/2015
AP05/19/2003SLR5817002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf 6/8/2003
AP05/19/2003SLR5818003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf 6/8/2003
AP05/19/2003SLR43423003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s003.pdf 7/20/2015
AP04/9/1999SCM       
AP05/19/2003SLR45077005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s005.pdf 2/2/2016
AP05/19/2003SLR5819005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf 6/8/2003
AP04/10/2000SLR       
AP09/21/2004SLR45078008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020599Orig1s008.pdf 2/2/2016
AP09/21/2004SLR10275008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20599s008ltr.pdf 9/24/2004
AP07/10/2009SLR22982011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s011,s012ltr.pdf 7/17/2009
AP07/10/2009SLR23040011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf 7/23/2009
AP07/10/2009SLR42078011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s011,s012.pdf 3/10/2015
AP07/12/2009SLR42079012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s011,s012.pdf 3/10/2015
AP07/12/2009SLR23041012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf 7/23/2009
AP07/12/2009SLR22983012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s011,s012ltr.pdf 7/17/2009
AP011/16/2009SLR23922013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s013lbl.pdf 11/17/2009
AP011/16/2009SLR24537013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s013ltr.pdf 1/20/2010
AP011/16/2009SLR42080013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s013.pdf 3/10/2015
AP04/8/2016SLR45635017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020599Orig1s017ltr.pdf 4/11/2016
AP04/8/2016SLR45659017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020599s017lbl.pdf 4/12/2016
AP09/27/2016SCM       




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