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FDA Drug Application 019982 by TEVA WOMENS

Application Number019982
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
AP07/31/1992N3779000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982_Zebeta.cfm 8/1/2001
AP06/11/1993SCE3781001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S1_Zebeta.pdf 8/1/2001
AP05/30/1995SLR3782003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S3_Zebeta.pdf 8/1/2002
AP01/14/1997SCM4356004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19982-S4_Zebeta.pdf 1/14/1997
AP06/23/1998SCM2036005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19982-S5_Zebeta.pdf 6/23/1998
AP02/19/1998SCP2037006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19982-S6_Zebeta.pdf 2/19/1998
AP04/4/2000SLR       
AP01/24/2003SLR9658010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr010ltr.pdf 7/1/2004
AP09/25/2007SLR18047014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014, 020186s023ltr.pdf 9/26/2007
AP09/25/2007SLR26203014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019982s014lbl.pdf 8/12/2010
AP02/3/2011SLR27713016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019982s016lbl.pdf 2/4/2011
AP02/3/2011SLR27813016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019982s016ltr.pdf 2/10/2011
AP08/28/2013SCM       
AP06/12/2014SCM       




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