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FDA Drug Application 020312 by UCB INC

Application Number020312
Application Type New Drug Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/19/1995N14277000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP04/19/1995N3750000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-312_Moexipril_Univasc.pdf 9/13/2002
AP010/18/1995SCS       
AP010/18/1995SCM       
AP010/18/1995SCP       
AP01/17/1996SCM       
AP07/9/1996SCS       
AP09/3/1996SCP       
AP011/8/1996SCS       
AP09/3/1998SCM       
AP04/8/1998SLR       
AP02/11/1999SCM       
AP010/29/1999SCM       
AP07/18/2000SCM       
AP02/2/2000SLR       
AP03/28/2001SCP       
AP04/11/2001SLR1596016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20312S16ltr.pdf 4/11/2001
AP09/24/2001SCS       
AP010/2/2001SCS       
AP012/9/2002SCP       
AP010/29/2003SLR6980024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf 11/25/2003
AP01/13/2010SLR24515031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020312s031ltr.pdf 1/15/2010
AP01/13/2010SLR24684031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf 1/29/2010
AP08/23/2011SLR29893033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020312s033ltr.pdf 8/26/2011
AP08/23/2011SLR29948033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf 9/2/2011
AP01/19/2012SLR31440034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf 1/23/2012
AP01/19/2012SLR31442034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf 1/23/2012
AP09/14/2012SLR33775035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312Orig1s035ltr.pdf 9/18/2012
AP09/14/2012SLR33786035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf 9/18/2012




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