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FDA Drug Application 050801 by DELCOR ASSET CORP

Application Number050801
Application Type New Drug Application
Sponsor ApplicantDELCOR ASSET CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/2004N10620000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21709ltr.pdf 10/22/2004
AP010/22/2004N10621000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf 10/22/2004
AP010/22/2004N10622000Application Number Change Letter  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21709to50801_Num_Change_ltr.pdf 11/17/2004
AP010/22/2004N15207000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050801s000_EvoclinTOC.cfm 10/25/2006
AP07/11/2006SLR14447006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf 7/13/2006
AP07/11/2006SLR14449006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050801s006LTR.pdf 7/13/2006
AP012/21/2010SLR27312011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf 12/20/2010
AP012/21/2010SLR27329011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050801s011ltr.pdf 12/22/2010
AP01/20/2012SLR31504015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf 1/24/2012
AP01/20/2012SLR31508015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050801s015ltr.pdf 1/25/2012
AP01/20/2015SCM       




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