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FDA Drug Application 020186 by TEVA WOMENS

Application Number020186
Application Type New Drug Application
Sponsor ApplicantTEVA WOMENS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/26/1993N       
AP09/7/1993SCE       
AP011/24/1993SCS       
AP04/15/1994SCS       
AP05/30/1995SLR3783004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S3_Zebeta.pdf 8/1/2001
AP04/24/1996SLR       
AP010/9/1996SCS       
AP01/15/1998SCP       
AP04/1/1998SLR       
AP02/16/1999SCM       
AP06/22/1999SCS       
AP04/4/2000SLR       
AP01/24/2003SLR9657015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr010ltr.pdf 7/1/2004
AP09/25/2007SLR18046023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014, 020186s023ltr.pdf 9/26/2007
AP09/25/2007SLR26204023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020186s023lbl.pdf 8/12/2010
AP011/6/2009SLR24032026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020186s026lbl.pdf 11/19/2009
AP011/6/2009SLR24533026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020186s026ltr.pdf 1/19/2010
AP05/3/2011SLR28705027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020186s027s028lbl.pdf 5/5/2011
AP05/3/2011SLR       
AP012/12/2013SCM       
AP06/12/2014SCM       
AP07/27/2015SCM       




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