Back to FDA Applications sponsored by TOLMAR THERAP

FDA Drug Application 021379 by TOLMAR THERAP

Application Number021379
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
AP07/24/2002N1751000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21379ltr.pdf 7/24/2002
AP07/24/2002N1752000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21379lbl.pdf 7/24/2002
AP07/24/2002N1753000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-379_Eligard.cfm 7/24/2002
AP07/24/2002N31124000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP01/12/2004SLR8940002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf 6/3/2004
AP01/12/2004SLR20357002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021379_s002_ELIGARD.pdf 7/31/2008
AP011/8/2007SLR18410010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf 11/13/2007
AP011/8/2007SLR18446010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf 11/19/2007
AP010/5/2010SLR26630014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf 10/12/2010
AP010/5/2010SLR26645014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf 10/13/2010
AP01/14/2011SLR27549015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf 1/20/2011
AP01/14/2011SLR27560015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf 1/20/2011
AP04/8/2011SLR28502016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf 4/11/2011
AP04/8/2011SLR28515016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf 4/11/2011
AP01/25/2013SCM       
AP02/8/2013SCM       
AP02/27/2013SLR35279025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf 3/1/2013
AP02/27/2013SLR35313025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf 3/1/2013
AP07/18/2014SCM       
AP02/3/2014SCM       
AP04/15/2014SCM       
AP010/10/2014SLR40767030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf 10/14/2014
AP010/10/2014SLR40782030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf 10/15/2014
AP02/29/2016SLR45304033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf 3/2/2016
AP02/29/2016SLR45358033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf 3/3/2016




Back to FDA Applications sponsored by TOLMAR THERAP