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FDA Drug Application 021731 by TOLMAR THERAP

Application Number021731
Application Type New Drug Application
Sponsor ApplicantTOLMAR THERAP
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
AP012/14/2004N15005000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021731s000_EligardTOC.cfm 9/27/2006
AP012/14/2004N31126000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP19/29/2006SCP15052004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021731s004LTR.pdf 10/5/2006
AP011/8/2007SLR18408005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf 11/13/2007
AP011/8/2007SLR18445005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf 11/19/2007
AP010/5/2010SLR26628010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf 10/12/2010
AP010/5/2010SLR26647010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf 10/13/2010
AP01/14/2011SLR27551012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf 1/20/2011
AP01/14/2011SLR27562012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf 1/20/2011
AP04/8/2011SLR28500013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf 4/11/2011
AP04/8/2011SLR28517013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf 4/11/2011
AP04/3/2013SCM       
AP02/27/2013SLR35281023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf 3/1/2013
AP02/27/2013SLR35310023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf 3/1/2013
AP07/18/2014SCM       
AP010/10/2014SLR40769027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf 10/14/2014
AP010/10/2014SLR40780027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf 10/15/2014
AP02/29/2016SLR45306029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf 3/2/2016
AP02/29/2016SLR45356029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf 3/3/2016




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