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FDA Drug Application 020189 by MEDA PHARMS

Application Number020189
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/1993N19005000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm 2/1/2008
AP09/17/1993SCM       
AP012/20/1993SCM       
AP012/21/1993SCM       
AP03/2/1994SLR       
AP05/31/1994SCF       
AP011/1/1994SLR       
AP011/1/1994SLR       
AP011/29/1994SLR       
AP01/24/1995SCE       
AP06/26/1995SCS       
AP08/28/1995SCS       
AP011/19/2002SLR1843018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20189slr018ltr.pdf 11/19/2002
AP06/26/2002SCM       
AP04/23/2009SLR22381022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020189s022ltr.pdf 5/1/2009
AP04/23/2009SLR22557022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf 5/13/2009
AP07/6/2011SLR29442023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020189s023ltr.pdf 7/7/2011
AP07/6/2011SLR29451023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf 7/7/2011
AP07/6/2011SLR29452023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023MedG.pdf 7/7/2011
AP08/31/2012SLR33640027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020189Orig1s027ltr.pdf 9/5/2012
AP08/31/2012SLR33674027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf 9/6/2012
AP08/31/2012SLR33675027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf 9/6/2012




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