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FDA Drug Application 018554 by SCHERING

Application Number018554
Application Type New Drug Application
Sponsor ApplicantSCHERING
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
AP01/27/1989N       
AP010/17/1989SLR       
AP07/29/1992SCM       
AP09/3/1990SLR       
AP08/30/1996SCS       
AP05/7/1991SCS       
AP07/22/1993SCM       
AP05/18/1992SCM       
AP09/19/1991SLR       
AP010/26/1994SLR       
AP09/15/1995SLR       
AP011/15/1995SCM       
AP06/21/1996SE1       
AP08/19/1999SLR       
AP011/12/1997SCS       
AP05/18/1998SCS       
AP01/7/2000SCM       
AP01/23/2001SCM       
AP03/14/2001SCS       
AP03/23/2001SLR1622021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S21LTR.PDF 3/23/2001
AP03/23/2001SLR11055021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S021.pdf 1/28/2005
AP03/30/2001SLR1623022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S22LTR.PDF 3/30/2001
AP03/30/2001SLR11056022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S022.pdf 1/28/2005
AP07/23/2001SLR5224023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf 4/14/2003




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