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FDA Drug Application 021488 by TOLMAR THERAP

Application Number021488
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
AP02/13/2003N8941000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-488_Eligard_Approv.pdf 6/3/2004
AP02/13/2003N31125000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP02/13/2003N3960000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021488lbl.pdf 2/13/2003
AP02/13/2003N5614000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021488_eligard.cfm 5/8/2003
AP01/12/2004SLR7537002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf 1/14/2004
AP011/8/2007SLR18409010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf 11/13/2007
AP011/8/2007SLR18447010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf 11/19/2007
AP010/5/2010SLR26629015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf 10/12/2010
AP010/5/2010SLR26646015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf 10/13/2010
AP01/14/2011SLR27550016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf 1/20/2011
AP01/14/2011SLR27561016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf 1/20/2011
AP04/8/2011SLR28501017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf 4/11/2011
AP04/8/2011SLR28516017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf 4/11/2011
AP02/27/2013SLR35280025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf 3/1/2013
AP02/27/2013SLR35312025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf 3/1/2013
AP010/10/2014SLR40768027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf 10/14/2014
AP010/10/2014SLR40781027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf 10/15/2014
AP02/29/2016SLR45305030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf 3/2/2016
AP02/29/2016SLR45357030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf 3/3/2016




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