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FDA Drug Application 022377 by MERIDIAN MEDCL

Application Number022377
Application Type New Drug Application
Sponsor ApplicantMERIDIAN MEDCL
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
AP06/29/2010N25903000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022377s000ltr.pdf 7/2/2010
AP06/29/2010N25921000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022377s000lbl.pdf 7/6/2010
AP06/29/2010N28779000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377_alsuma_toc.cfm 5/11/2011
AP06/29/2010N28780000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377Orig1s000SumR.pdf 5/11/2011
AP06/5/2014SLR39453002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf 6/10/2014
AP06/5/2014SLR39493002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf 6/10/2014
AP04/15/2013SCM       
AP06/5/2014SLR39454004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf 6/10/2014
AP06/5/2014SLR39494004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf 6/10/2014




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