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FDA Drug Application 021316 by COVIS PHARMA SARL

Application Number021316
Application Type New Drug Application
Sponsor ApplicantCOVIS PHARMA SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/26/2002N4373000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316ltr.pdf 6/26/2002
AP06/26/2002N4374000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316lbl.pdf 6/26/2002
AP06/26/2002N5526000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_altocor.cfm 4/30/2003
AP09/11/2002SE14372001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf 9/11/2002
AP09/11/2002SE18815001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316se1-001ltr.pdf 5/28/2004
AP09/11/2002SE117159001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_S001_ALTOCOR_AP.pdf 7/9/2007
AP012/18/2002SCM       
AP08/20/2003SLR6566005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr005ltr.pdf 8/28/2003
AP09/24/2003SLR6711006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr006ltr.pdf 9/30/2003
AP09/24/2003SLR6712006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21316slr006_lovastatin_lbl.pdf 9/30/2003
AP09/24/2003SLR16330006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021316_S006_ALTOCAR_TABLETS_AP.pdf 4/30/2007
AP07/21/2004SLR9835010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21316s010ltr.pdf 7/21/2004
AP07/21/2004SLR9842010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21316s010lbl.pdf 7/21/2004
AP02/1/2007SLR15789018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021316s018ltr.pdf 2/12/2007
AP04/26/2012SLR32543026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf 4/27/2012
AP04/26/2012SLR32588026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316s026ltr.pdf 5/2/2012
AP012/21/2012SLR34767028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s028ltr.pdf 12/27/2012
AP012/21/2012SLR34796028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf 12/28/2012
AP010/31/2012SLR34226029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf 11/2/2012
AP010/31/2012SLR34256029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s029ltr.pdf 11/5/2012
AP05/15/2013SCM       
AP15/15/2013SCM       
AP04/30/2014SLR39187031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021316Orig1s031ltr.pdf 5/1/2014
AP04/30/2014SLR39202031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021316s031lbl.pdf 5/2/2014
AP05/18/2015SCM       
AP09/14/2015SCM       




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