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FDA Drug Application 040361 by BARR

Application Number040361
Application Type Abbreviated New Drug Application
Sponsor ApplicantBARR
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
AP01/31/2001N6263000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040361_dextroamphetamine_toc.cfm 7/31/2003
AP01/31/2001N8909000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Approv.pdf 6/2/2004
AP01/31/2001N8910000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Prntlbl.pdf 6/2/2004
AP02/14/2002SCB       
AP02/14/2002SCR       
AP02/14/2002SCS       
AP02/14/2002SCR       
AP03/29/2014SLR38960017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040361Orig1s017ltr.pdf 4/3/2014
AP03/29/2014SLR40169017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf 8/6/2014
AP04/17/2015SLR       




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