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FDA Drug Application 019774 by FERRING

Application Number019774
Application Type New Drug Application
Sponsor ApplicantFERRING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/25/1995N       
AP08/29/1996SCS       
AP09/9/1996SCS       
AP011/3/1999SCS       
AP02/3/2000SCM       
AP08/17/2000SLR       
AP04/9/2002SCS       
AP01/4/2002SCS       
AP03/16/2005SLR20335009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019774_s009_TEV TROPIN.pdf 7/30/2008
AP03/16/2005SLR11262009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19774s009ltr.pdf 3/18/2005
AP03/16/2005SLR11269009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19774s009lbl.pdf 3/18/2005
AP02/15/2007SLR15858014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019774s014lbl.pdf 2/21/2007
AP02/15/2007SLR15888014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019774s014ltr.pdf 2/23/2007
AP06/25/2009SCS22855016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019774s016ltr.pdf 6/30/2009
AP04/12/2010SLR25259019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019774s019lbl.pdf 4/13/2010
AP04/12/2010SLR25264019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019774s019ltr.pdf 4/15/2010
AP07/19/2011SLR29560023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019774s023lbl.pdf 7/20/2011
AP07/19/2011SLR29570023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019774s023ltr.pdf 7/21/2011
AP03/4/2015SLR42034026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s026lbl.pdf 3/5/2015
AP03/4/2015SLR42037026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019774Orig1s026ltr.pdf 3/6/2015
AP06/16/2014SLR39585027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019774Orig1s027ltr.pdf 6/19/2014
AP06/16/2014SLR39624027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s027lbl.pdf 6/23/2014
AP010/29/2014SLR40899028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019774Orig1s028ltr.pdf 10/30/2014
AP010/29/2014SLR40946028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s028lbl.pdf 11/4/2014
AP08/6/2015SCM       
AP06/12/2015SLR43059031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019774Orig1s031ltr.pdf 6/15/2015
AP06/12/2015SLR43064031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s031lbl.pdf 6/15/2015
AP07/30/2015SCM       
AP02/26/2016SCM       
AP09/30/2016SLR47275036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019774Orig1s036ltr.pdf 10/4/2016
AP09/30/2016SLR47305036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s036lbl.pdf 10/6/2016




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