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FDA Drug Application 016012 by TEVA WOMENS

Application Number016012
Application Type New Drug Application
Sponsor ApplicantTEVA WOMENS
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
AP09/27/1967N16546000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP05/5/1983SCS       
AP03/29/1977SCS       
AP01/25/1978SCP       
AP01/29/1980SCM       
AP05/12/1980SLR       
AP03/10/1981SCF       
AP03/10/1981SCF       
AP03/6/1981SLR       
AP02/18/1982SLR       
AP06/9/1983SCS       
AP07/16/1984SLR       
AP09/20/1985SLR       
AP01/21/1986SLR       
AP03/18/1988SCS       
AP04/13/1987SLR       
AP04/8/1988SCP       
AP08/26/1993SCS       
AP06/1/1994SCM       
AP03/27/2000SLR       
AP04/15/1996SCM       
AP03/27/2000SLR       
AP012/27/1996SCS       
AP012/4/1997SCS       
AP011/4/1998SCS       
AP04/11/2000SLR       
AP04/11/2000SLR       
AP04/11/2000SLR       
AP07/17/2014SLR39902053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016012Orig1s053ltr.pdf 7/21/2014




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