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FDA Drug Application 019796 by MERCK SHARP DOHME

Application Number019796
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP03/30/1989N       
AP06/13/1989SCP       
AP09/25/1991SCS       
AP03/11/1992SCP       
AP01/25/1996SCM       
AP04/16/1996SCS       
AP07/17/2002SLR1762008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf 7/17/2002
AP07/17/2002SLR1763008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf 7/17/2002
AP06/5/1998SCM       
AP011/2/1998SCS       
AP012/28/1998SCM       
AP05/14/1999SCS       
AP09/7/2000SCP       
AP07/13/2001SCS       
AP07/17/2002SE51764015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf 7/17/2002
AP07/17/2002SE51765015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf 7/17/2002
AP09/9/2005SLR12780020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019796s020ltr.pdf 9/15/2005
AP09/9/2005SLR12803020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf 9/15/2005
AP03/28/2013SLR35581026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019796Orig1s026ltr.pdf 4/1/2013
AP03/28/2013SLR35615026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf 4/1/2013




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