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FDA Drug Application 022104 by OSMOTICA PHARM

Application Number022104
Application Type New Drug Application
Sponsor ApplicantOSMOTICA PHARM
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
AP05/20/2008N19868000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022104s000ltr.pdf 5/21/2008
AP05/20/2008N19902000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm 5/30/2008
AP05/20/2008N20247000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022104s000_SumR.pdf 7/17/2008
AP05/20/2008N23088000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022104_venlafaxine_hydrochloride_toc.cfm 7/29/2009
AP02/27/2009SCP21954002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022104s002ltr.pdf 3/5/2009
AP02/27/2009SCP22194002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf 4/3/2009
AP01/30/2009SLR21717003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022104s003ltr.pdf 2/3/2009
AP01/30/2009SLR21790003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s003lbl.pdf 2/4/2009
AP07/31/2012S33330007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104Orig1s007ltr.pdf 8/2/2012
AP05/2/2012SLR32621008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104s008ltr.pdf 5/4/2012
AP05/2/2012SLR32643008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s008lbl.pdf 5/7/2012
AP012/11/2012SLR34621009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s009lbl.pdf 12/13/2012
AP012/11/2012SLR34657009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104Orig1s009ltr.pdf 12/13/2012
AP07/18/2014SLR39932010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022104Orig1s010ltr.pdf 7/23/2014
AP07/18/2014SLR40062010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022104s010lbl.pdf 7/30/2014
AP07/18/2014SLR40096010   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM406909.pdf 8/1/2014
AP06/21/2016SCM       
AP03/24/2016SCM       




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