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FDA Drug Application 009330 by COVIS PHARMA SARL

Application Number009330
Application Type New Drug Application
Sponsor ApplicantCOVIS PHARMA SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/6/1991SCS       
AP05/7/1992SLR       
AP08/6/1993SCS       
AP08/30/1995SLR       
AP06/25/1996SLR       
AP07/15/1998SLR2774020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/9330-s020_lanoxin.pdf 9/14/2001
AP06/17/2002SCM2773021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9330s021ltr.pdf 6/17/2002
AP02/5/2010SLR24765025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009330s025lbl.pdf 2/16/2010
AP02/5/2010SLR25064025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009330s025ltr.pdf 3/18/2010
AP011/14/2011SLR30582026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009330s026lbl.pdf 11/14/2011
AP011/14/2011SLR30594026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009330s026ltr.pdf 11/16/2011
AP05/16/2013SLR36098027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009330s027lbl.pdf 5/21/2013
AP05/16/2013SLR36115027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009330Orig1s027ltr.pdf 5/22/2013
AP07/28/2015SLR43512030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009330Orig1s030ltr.pdf 7/29/2015
AP07/28/2015SLR43539030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009330s030lbl.pdf 7/30/2015




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