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FDA Drug Application 022025 by CLINIGEN HLTHCARE

Application Number022025
Application Type New Drug Application
Sponsor ApplicantCLINIGEN HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/6/2007N17811000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022025lbl.pdf 9/10/2007
AP09/6/2007N17863000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022025s000_ltr.pdf 9/11/2007
AP09/6/2007N24114000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022025_totect_toc.cfm 11/24/2009
AP09/6/2007N24116000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022025s000_SumR.pdf 11/24/2009
AP02/11/2009SLR21808001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s001lbl.pdf 2/12/2009
AP02/11/2009SLR21851001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022025s001ltr.pdf 2/18/2009
AP09/16/2009SLR23422005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s005lbl.pdf 9/21/2009
AP09/16/2009SLR23779005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022025s005ltr.pdf 11/10/2009
AP03/7/2011SLR28188011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022025s011ltr.pdf 3/10/2011
AP04/26/2013SLR35863013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022025s013lbl.pdf 4/29/2013
AP04/26/2013SLR35887013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022025Orig1s013ltr.pdf 4/30/2013
AP02/12/2013SCM       




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