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FDA Drug Application 101063 by MERCK

Application Number101063
Application Type Biologic License Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/1/1994N       
AP08/1/2002S79255012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/aspamer080102L.pdf 3/12/2004
AP08/1/2002S79265012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/aspamer080102LB.pdf 3/12/2004
AP06/29/2004S97225036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/101063_5036ltr.pdf 7/7/2004
AP07/13/2006S144825071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/101063s5071lbl.pdf 7/21/2006
AP07/13/2006S145245071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/101063 5071 Ltr.pdf 7/25/2006
AP03/30/2007S162485081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/101063s5081LTR.pdf 4/20/2007
AP03/30/2007S162825081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/101063s5081LBL.pdf 4/20/2007
AP07/16/2013SLR365675169   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/101063s5169lbl.pdf 7/17/2013
AP07/16/2013SLR365725169   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/101063Orig1s5169ltr.pdf 7/18/2013




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