Back to FDA Applications sponsored by TOLMAR THERAP

FDA Drug Application 021343 by TOLMAR THERAP

Application Number021343
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
AP01/23/2002N1755000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343ltr.pdf 1/23/2002
AP01/23/2002N1756000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21343lbl.pdf 1/23/2002
AP01/23/2002N1757000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-343_Eligard.cfm 1/23/2002
AP01/23/2002N31123000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP04/1/2002SLR1754001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343s001ltr.pdf 4/1/2002
AP07/3/2003SLR6093002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21343slr002ltr.pdf 7/8/2003
AP01/12/2004SLR7536004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf 1/14/2004
AP011/8/2007SLR18411015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf 11/13/2007
AP011/8/2007SLR18444015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf 11/19/2007
AP010/5/2010SLR26631018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf 10/12/2010
AP010/5/2010SLR26644018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf 10/13/2010
AP01/14/2011SLR27548019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf 1/20/2011
AP01/14/2011SLR27559019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf 1/20/2011
AP04/8/2011SLR28503020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf 4/11/2011
AP04/8/2011SLR28514020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf 4/11/2011
AP04/9/2013SCM       
AP02/27/2013SLR35278027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf 3/1/2013
AP02/27/2013SLR35314027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf 3/1/2013
AP07/18/2014SCM       
AP05/30/2014SCM       
AP010/10/2014SLR40766030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf 10/14/2014
AP010/10/2014SLR40783030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf 10/15/2014
AP010/10/2014SCM       
AP010/26/2015SCM       
AP02/29/2016SLR45303033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf 3/2/2016
AP02/29/2016SLR45359033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf 3/3/2016
AP02/29/2016SLR46729033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021343Orig1s033.pdf 8/5/2016




Back to FDA Applications sponsored by TOLMAR THERAP