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FDA Drug Application 075932 by SANDOZ

Application Number075932
Application Type Abbreviated New Drug Application
Sponsor ApplicantSANDOZ
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA01/24/2002TA5156000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75932TAF.pdf 4/10/2003
TA01/24/2002TA12335000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm 7/28/2005
TA01/24/2002TA17374000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075932_ORIGINAL APPROVAL_PACKAGE.pdf 7/24/2007
AP111/25/2003N5156000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75932TAF.pdf 4/10/2003
AP111/25/2003N12335000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm 7/28/2005
AP111/25/2003N17374000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075932_ORIGINAL APPROVAL_PACKAGE.pdf 7/24/2007
AP03/22/2004S7996001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf 3/24/2004
AP03/22/2004S17034001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075932_S001_AP.pdf 7/6/2007
AP03/22/2004S7997002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf 3/24/2004
AP03/22/2004S17033002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075932_S002_AP.pdf 7/6/2007
AP06/22/2005S       
AP06/22/2005S       
AP06/22/2005S       
AP06/22/2005S       
AP011/25/2014SLR       
AP011/25/2014SLR       




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