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FDA Drug Application 021997 by MEDA PHARMS

Application Number021997
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/13/2009N22047000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021997s000ltr.pdf 3/19/2009
AP03/13/2009N22121000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021997lbl.pdf 3/26/2009
AP03/13/2009N22742000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.cfm 6/12/2009
AP03/13/2009N22743000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.cfm 6/12/2009
AP03/13/2009N23952000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135937.pdf 11/18/2009
AP012/17/2010SLR27301002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021997s002ltr.pdf 12/21/2010
AP08/10/2011SLR30045003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021997s003ltr.pdf 9/20/2011
AP04/19/2013SLR35790005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021997s005lbl.pdf 4/23/2013
AP04/19/2013SLR35825005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021997Orig1s005ltr.pdf 4/24/2013
AP010/29/2014SLR40900006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021997Orig1s006ltr.pdf 10/30/2014
AP010/29/2014SLR40945006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf 11/4/2014




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