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FDA Drug Application 021660 by ABRAXIS BIOSCIENCE

Application Number021660
Application Type New Drug Application
Sponsor ApplicantABRAXIS BIOSCIENCE
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
AP01/7/2005N10917000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf 1/10/2005
AP01/7/2005N10935000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021660ltr.pdf 1/11/2005
AP01/7/2005N11826000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21660_AbraxaneTOC.cfm 6/16/2005
AP02/15/2007SE815893010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021660s010ltr.pdf 2/23/2007
AP02/15/2007SE815905010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021660s010lbl.pdf 2/23/2007
AP02/15/2007SE833771010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021660Orig1s010.pdf 9/17/2012
AP07/1/2008SLR32224013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021660Orig1s013.pdf 3/27/2012
AP07/1/2008SLR20156013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021660s013ltr.pdf 7/7/2008
AP07/1/2008SLR20172013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021660s013lbl.pdf 7/9/2008
AP06/26/2009SLR22840022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021660s022lbl.pdf 6/29/2009
AP06/26/2009SLR22856022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021660s022ltr.pdf 6/30/2009
AP06/26/2009SLR32225022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021660Orig1s022.pdf 3/27/2012
AP012/23/2011SLR31330025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf 1/3/2012
AP012/23/2011SLR31524025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf 1/26/2012
AP012/23/2011SLR31525026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf 1/26/2012
AP012/23/2011SLR31331026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf 1/3/2012
AP012/23/2011SLR31526029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf 1/26/2012
AP012/23/2011SLR31329029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf 1/3/2012
AP010/11/2012SE134041031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s031lbl.pdf 10/12/2012
AP010/11/2012SE134089031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s031ltr.pdf 10/15/2012
AP010/11/2012SE142048031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021660Orig1s031.pdf 3/9/2015
AP012/10/2012SCM       
AP09/28/2012SLR33976034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf 10/4/2012
AP09/28/2012SLR33947034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf 10/3/2012
AP09/28/2012SLR33948035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf 10/3/2012
AP09/28/2012SLR33977035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf 10/4/2012
AP06/7/2013SLR36258036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s036ltr.pdf 6/11/2013
AP06/7/2013SLR36264036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf 6/11/2013
AP09/6/2013SE136960037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf 9/6/2013
AP09/6/2013SE137038037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s037ltr.pdf 9/10/2013
AP010/30/2013SLR37623038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s038ltr.pdf 10/31/2013
AP010/30/2013SLR37640038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s038lbl.pdf 10/31/2013
AP04/28/2014SCM       
AP012/11/2014SLR41231040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021660Orig1s040ltr.pdf 12/12/2014
AP012/11/2014SLR41542040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf 1/8/2015
AP07/21/2015SLR43429041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021660Orig1s041ltr.pdf 7/22/2015
AP07/21/2015SLR43452041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf 7/22/2015
AP011/2/2015SCM       
AP03/24/2016SCM       




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