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FDA Drug Application 018680 by TEVA WOMENS

Application Number018680
Application Type New Drug Application
Sponsor ApplicantTEVA WOMENS
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
AP011/15/1984N27839000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018680_original_approval.pdf 2/15/2011
AP04/29/1988SLR       
AP011/18/1988SCS       
AP010/17/1988SLR       
AP07/17/1989SE2       
AP03/1/1989SLR       
AP07/24/1989SLR       
AP07/24/1989SLR       
AP09/24/1990SLR       
AP03/22/1991SCS       
AP011/25/1991SCS       
AP05/3/1991SLR       
AP08/13/1991SE2       
AP07/17/1991SCM       
AP011/25/1991SCS       
AP011/25/1991SCP       
AP011/20/1991SLR       
AP011/25/1991SLR       
AP06/17/1993SCE       
AP05/19/1994SE2       
AP07/24/1995SCM       
AP01/24/1996SCS       
AP01/18/1996SCP       
AP04/12/1996SCS       
AP04/12/1996SCS       
AP05/17/1996SCS       
AP02/14/1997SCS       
AP03/13/1997SCS       
AP06/4/1997SCS       
AP010/9/1997SCS       
AP011/3/1997SCS       
AP02/10/1998SCS       
AP07/7/1998SCS       
AP07/7/1998SCS       
AP05/29/1998SCS       
AP05/29/1998SCM       
AP02/2/1999SCS       
AP02/2/1999SCS       
AP07/23/1999SCM       
AP07/23/1999SCM       
AP012/14/1999SCS       
AP03/27/2000SCM       
AP04/25/2000SCS       
AP09/20/2000SCM       
AP08/24/2001SLR5518055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18680s55lbl.pdf 4/30/2003
AP09/27/2001SCM       
AP04/22/2003SLR5721057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18680slr057ltr.pdf 5/29/2003
AP09/1/2005SE812733060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf 9/8/2005
AP09/1/2005SE812734060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018680s060ltr.pdf 9/8/2005
AP06/11/2013SLR36283066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018680Orig1s066ltr.pdf 6/13/2013
AP06/11/2013SLR36316066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018680s066lbl.pdf 6/18/2013
AP02/20/2014SCM       




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