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FDA Drug Application 022383 by NOVARTIS

Application Number022383
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/1/2011N29381000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf 7/5/2011
AP07/1/2011N29382000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf 7/5/2011
AP07/1/2011N29441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022383s000ltr.pdf 7/7/2011
AP07/1/2011N29647000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM266276.pdf 8/2/2011
AP07/1/2011N29758000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000TOC.cfm 8/12/2011
AP07/1/2011N29759000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000SumR.pdf 8/12/2011
AP09/26/2012SLR33851002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002lbl.pdf 9/26/2012
AP09/26/2012SLR33852002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002mg.pdf 9/26/2012
AP09/26/2012SLR33867002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s002ltr.pdf 9/27/2012
AP02/25/2013SCM       
AP012/18/2012SLR34751004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf 12/26/2012
AP012/18/2012SLR34752005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf 12/26/2012




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