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FDA Drug Application 021305 by JUBILANT DRAXIMAGE

Application Number021305
Application Type New Drug Application
Sponsor ApplicantJUBILANT DRAXIMAGE
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
AP01/24/2003N4180000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305ltr.pdf 1/24/2003
AP01/24/2003N4181000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21305_Sodium-Iodide_lbl.pdf 1/24/2003
AP01/24/2003N6014000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021305_sodiumiodide.cfm 6/26/2003
AP08/8/2003SLR6522001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305slr001ltr.pdf 8/15/2003
AP011/18/2004SCS10673002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21305s002ltr.pdf 12/2/2004
AP05/19/2005SE111670003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021305s003ltr.pdf 5/20/2005
AP05/19/2005SE111688003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021305s003lbl.pdf 5/20/2005
AP01/6/2006SLR13375005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021305s005lbl.pdf 1/10/2006
AP01/6/2006SLR13432005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021305s005ltr.pdf 1/20/2006
AP010/23/2006SLR15254010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021305s010ltr.pdf 10/26/2006
AP04/18/2007SLR16262011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021305s011lbl.pdf 4/20/2007
AP04/18/2007SLR16307011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021305s011_LTR.pdf 4/25/2007
AP02/29/2008SLR19357016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021305s016ltr.pdf 3/4/2008
AP02/29/2008SLR19368016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021305s016lbl.pdf 3/5/2008
AP09/23/2011SLR30104025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021305s025ltr.pdf 9/28/2011
AP09/23/2011SLR30127025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s025lbl.pdf 9/29/2011
AP010/3/2011SCM30209027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s027lbl.pdf 10/3/2011
AP010/3/2011SCM30222027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021305s027ltr.pdf 10/5/2011
AP012/7/2012SCM       
AP012/7/2012SCM       
AP09/26/2014SCM       
AP02/3/2015SCM       
AP04/1/2016SCM       
AP07/31/2015SCM       
AP06/15/2016SLR46362041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021305Orig1s041ltr.pdf 6/21/2016
AP06/15/2016SLR46376041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021305s041lbl.pdf 6/21/2016
AP07/8/2016SLR46508042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021305Orig1s042ltr.pdf 7/12/2016
AP07/8/2016SLR46736042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021305s042lbl.pdf 8/8/2016




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