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FDA Drug Application 022196 by AMHERST PHARMS LLC

Application Number022196
Application Type New Drug Application
Sponsor ApplicantAMHERST PHARMS LLC
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
AP012/19/2008N21423000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022196S000ltr.pdf 12/29/2008
AP012/19/2008N21507000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf 1/6/2009
AP012/19/2008N23012000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000TOC.cfm 7/22/2009
AP012/19/2008N23013000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_SumR.pdf 7/22/2009
AP012/19/2008N24208000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143465.pdf 12/4/2009
AP012/19/2008N35854000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 4/29/2013
AP010/11/2010SLR26669003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022196s003ltr.pdf 10/19/2010
AP09/28/2011SLR30182007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022196s007ltr.pdf 10/3/2011




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