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FDA Drug Application 207026 by BAXTER HLTHCARE

Application Number207026
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP01/13/2015N41623000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207026s000lbl.pdf 1/14/2015
AP01/13/2015N41629000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207026Orig1s000ltr.pdf 1/15/2015
AP01/13/2015N42448000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207026Orig1s000TOC.cfm 4/7/2015
AP01/13/2015N42449000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207026Orig1s000SumR.pdf 4/7/2015
AP012/15/2015SLR44789001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021703Orig1s016,207026Orig1s001ltr.pdf 12/17/2015
AP012/15/2015SLR44800001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021703s016-207026s001lbl.pdf 12/17/2015
AP07/20/2016SLR46578002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.pdf 7/21/2016
AP07/20/2016SLR46595002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021703Orig1s017,207026Orig1s002ltr.pdf 7/22/2016
AP010/18/2016SCM       




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