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FDA Drug Application 020774 by DEXCEL PHARMA

Application Number020774
Application Type New Drug Application
Sponsor ApplicantDEXCEL PHARMA
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
AP05/15/1998N222000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20774ltr.pdf 5/15/1998
AP05/15/1998N223000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20774.cfm 5/15/1998
AP05/15/1998N224000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20774lbl.pdf 5/15/1998
AP04/5/1999SCS       
AP06/29/1999SCM       
AP012/15/2002SLR3376003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20774slr003ltr.pdf 12/15/2002
AP012/15/2002SLR3378003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20774slr003_perioChip_lbl.pdf 12/15/2002
AP03/22/2001SCS       
AP02/21/2002SCS       
AP03/2/2004SLR7807007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20774slr007ltr.pdf 3/3/2004
AP03/2/2004SLR8200007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20774slr007_periochiop_lbl.pdf 4/5/2004
AP06/8/2011SLR29141010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020774s010ltr.pdf 6/14/2011
AP06/8/2011SLR29454010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020774Orig1s010lbl.pdf 7/7/2011
AP01/12/2012SLR31394011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774s011ltr.pdf 1/17/2012
AP01/12/2012SLR31476011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s011lbl.pdf 1/23/2012
AP011/8/2012SLR34340012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s012lbl.pdf 11/8/2012
AP011/8/2012SLR34344012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774Orig1s012ltr.pdf 11/9/2012
AP07/3/2013SCM       
AP08/11/2016SCM       




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