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FDA Drug Application 010379 by KING PHARMS R AND D

Application Number010379
Application Type New Drug Application
Sponsor ApplicantKING PHARMS R AND D
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/8/1956N       
AP06/16/1975SLR       
AP03/7/1984SLR       
AP03/7/1984SLR       
AP02/19/1986SLR       
AP08/6/1990SCM       
AP03/28/1994SLR       
AP03/17/1995SLR       
AP06/2/1994SCM       
AP011/16/2000SCM       
AP07/18/2000SCM       
AP04/14/2001SCE       
AP09/13/2001SLR2671045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10379s45ltr.pdf 9/13/2001
AP02/27/2002SCS       
AP05/17/2002SLR2669047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10379S047ltr.pdf 5/17/2002
AP05/17/2002SLR2670047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf 5/17/2002




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