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FDA Drug Application 017970 by ASTRAZENECA

Application Number017970
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP012/30/1977N24025000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088661.pdf 11/19/2009
AP05/25/1978SCM       
AP07/24/1979SCE       
AP07/31/1979SLR       
AP010/2/1978SCS       
AP012/18/1979SCS       
AP03/29/1982SLR       
AP012/10/1985SLR       
AP08/20/1985SPD       
AP012/18/1984SCP       
AP04/5/1984SCS       
AP012/3/1986SE1       
AP011/25/1987SLR       
AP03/16/1989SE123307018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017970_S018_Nolvadex.pdf 9/14/2009
AP06/21/1990SE1       
AP03/14/1991SCS       
AP04/1/1993SE5       
AP03/21/1994SE2       
AP02/1/1995SLR       
AP01/23/1996SLR       
AP01/23/1996SLR       
AP01/23/1996SLR       
AP03/26/1996SLR       
AP011/15/1996SLR       
AP011/4/1996SCP       
AP05/16/2002SLR4861037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf 5/16/2002
AP05/16/2002SLR4862037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf 5/16/2002
AP06/11/1998SCS       
AP010/29/1998SE1770039   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf 10/29/1998
AP010/29/1998SE1771039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s39.pdf 10/29/1998
AP010/29/1998SE1772039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17970S39S40.cfm 10/29/1998
AP010/29/1998SE1874040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s40.pdf 10/29/1998
AP010/29/1998SE1875040   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf 10/29/1998
AP010/29/1998SE1876040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17970S39S40.cfm 10/29/1998
AP010/30/1998SLR       
AP04/2/1999SLR       
AP05/16/2002SLR4863044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf 5/16/2002
AP05/16/2002SLR4864044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf 5/16/2002
AP04/24/2000SCM       
AP06/29/2000SE11499046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/17970S46LTR.PDF 6/29/2000
AP06/29/2000SE11500046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/17970S46LBL.PDF 6/29/2000
AP06/29/2000SE12980046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/17-970S046_Nolvadex.cfm 6/29/2000
AP012/14/2000SCM       
AP06/10/2003SLR5949048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17970slr048ltr.pdf 6/22/2003
AP06/10/2003SLR6001048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17970slr048_nolvadex_lbl.pdf 6/22/2003
AP05/16/2002SLR2978049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf 5/16/2002
AP05/16/2002SLR2979049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf 5/16/2002
AP05/16/2002SLR6019049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex.cfm 7/5/2003
AP08/30/2002SLR2976050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21109and17970slr050ltr.pdf 8/30/2002
AP08/30/2002SLR2977050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21109lbl,17970s50lbl.pdf 8/30/2002
AP08/30/2002SLR4224050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21109_Nolvadex.cfm 3/7/2003
AP01/30/2003SLR6020051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex.cfm 7/5/2003
AP01/30/2003SLR9275051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_Approv.pdf 6/10/2004
AP01/30/2003SLR9276051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_prntlbl.pdf 6/10/2004
AP012/14/2004SLR10867052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17970s052ltr.pdf 12/30/2004
AP012/14/2004SLR10898052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf 12/30/2004
AP03/17/2005SLR11280053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17970s053ltr.pdf 3/23/2005
AP03/17/2005SLR11283053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf 3/23/2005
AP03/9/2006SE813751054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017970s054lbl.pdf 3/14/2006
AP03/9/2006SE813812054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017970s054ltr.pdf 3/23/2006




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