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FDA Drug Application 201525 by SANDOZ

Application Number201525
Application Type New Drug Application
Sponsor ApplicantSANDOZ
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
AP06/29/2011N29369000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201525s000lbl.pdf 6/30/2011
AP06/29/2011N29411000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201525s000ltr.pdf 7/6/2011
AP06/29/2011N31380000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525_docetaxel_toc.cfm 1/12/2012
AP06/29/2011N31381000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525Orig1s000SumR.pdf 1/12/2012
AP03/15/2012SLR32138002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf 3/16/2012
AP03/15/2012SLR32153002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201525s002ltr.pdf 3/19/2012
AP04/23/2014SLR39127003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s003ltr.pdf 4/24/2014
AP04/23/2014SLR39137003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf 4/25/2014
AP08/18/2014SCM       
AP011/4/2014SLR40951008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf 11/5/2014
AP011/4/2014SLR40962008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf 11/7/2014
AP011/4/2014SLR40952009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf 11/5/2014
AP011/4/2014SLR40963009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf 11/7/2014
AP07/25/2016SCM       
AP010/21/2016SLR47433012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201525Orig1s012ltr.pdf 10/25/2016
AP010/7/2016SCM       




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