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FDA Drug Application 021142 by DELCOR ASSET CORP

Application Number021142
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
AP05/26/2000N1384000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21142ltr.pdf 5/26/2000
AP05/26/2000N1385000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21142lbl.pdf 5/26/2000
AP05/26/2000N8092000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-142_Olux.cfm 3/28/2004
AP09/14/2000SCS       
AP011/29/2001SCS       
AP03/13/2002SCP2676003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142s3ltr.pdf 3/29/2002
AP012/20/2002SE13490004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142se1-004ltr.pdf 12/20/2002
AP012/20/2002SE14979004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21142se1-004_Olux_lbl.pdf 4/7/2003
AP08/21/2002SCM       
AP09/17/2002SCS       
AP07/21/2003SCM6178007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scm007ltr.pdf 7/28/2003
AP010/31/2003SLR6942009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142slr009ltr.pdf 11/25/2003
AP010/31/2003SLR7039009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142slr009_olux_lbl.pdf 12/2/2003
AP012/29/2003SCS7464010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142scs010_olux_lbl.pdf 1/2/2004
AP012/29/2003SCS7465010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scs010ltr.pdf 1/2/2004
AP07/11/2006SLR14514012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021142s012ltr.pdf 7/21/2006
AP06/7/2013SCM       
AP04/23/2014SLR39128019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021142Orig1s019ltr.pdf 4/24/2014
AP04/23/2014SLR39136019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021142s019lbl.pdf 4/25/2014




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