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FDA Drug Application 020355 by CSL BEHRING

Application Number020355
Application Type New Drug Application
Sponsor ApplicantCSL BEHRING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/7/1994N18620000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm 12/4/2007
AP010/2/1995SCS       
AP03/29/1996SLR       
AP03/21/2000SCS       
AP08/21/2002SLR3315004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20355slr004ltr.pdf 8/21/2002
AP010/24/2007SCF18333007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf 11/7/2007
AP010/24/2007SCF18371007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020355s007ltr.pdf 11/8/2007
AP09/16/2011SLR30049013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020355s013lbl.pdf 9/20/2011
AP09/16/2011SLR30053013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020355s013ltr.pdf 9/21/2011
AP05/24/2013SLR36150017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s017ltr.pdf 5/28/2013
AP05/24/2013SLR36226017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf 6/4/2013
AP01/25/2013SCM       
AP012/18/2013SCM       
AP06/10/2013SLR36250020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s020lbl.pdf 6/10/2013
AP06/10/2013SLR36278020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s020ltr.pdf 6/12/2013




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