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FDA Drug Application 022175 by DIGESTIVE CARE INC

Application Number022175
Application Type New Drug Application
Sponsor ApplicantDIGESTIVE CARE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/17/2012N32730000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000lbl.pdf 5/22/2012
AP05/17/2012N32731000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000mg.pdf 5/22/2012
AP05/17/2012N32742000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022175s000ltr.pdf 5/22/2012
AP05/17/2012N37229000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175_pertzye_toc.cfm 9/26/2013
AP05/17/2012N37230000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175Orig1s000SumR.pdf 9/26/2013
AP01/23/2014SCM       
AP010/6/2016SCM47310003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022175s003lbl.pdf 10/7/2016




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