Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017970
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOLVADEX TAMOXIFEN CITRATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
NOLVADEX TAMOXIFEN CITRATE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1977 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2006 SUPPL-54 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017970s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017970s054ltr.pdf
03/17/2005 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17970s053ltr.pdf
12/14/2004 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17970s052ltr.pdf
01/30/2003 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex.cfm
08/30/2002 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21109lbl,17970s50lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21109and17970slr050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21109_Nolvadex.cfm
05/16/2002 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex.cfm
06/10/2003 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17970slr048_nolvadex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17970slr048ltr.pdf
12/14/2000 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/29/2000 SUPPL-46 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/17970S46LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/17970S46LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/17-970S046_Nolvadex.cfm
04/24/2000 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/16/2002 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf
04/02/1999 SUPPL-43 Labeling

Label is not available on this site.

10/30/1998 SUPPL-41 Labeling

Label is not available on this site.

10/29/1998 SUPPL-40 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s40.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17970S39S40.cfm
10/29/1998 SUPPL-39 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s39.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17970S39S40.cfm
06/11/1998 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2002 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf
11/04/1996 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/15/1996 SUPPL-35 Labeling

Label is not available on this site.

03/26/1996 SUPPL-34 Labeling

Label is not available on this site.

01/23/1996 SUPPL-33 Labeling

Label is not available on this site.

01/23/1996 SUPPL-32 Labeling

Label is not available on this site.

01/23/1996 SUPPL-31 Labeling

Label is not available on this site.

02/01/1995 SUPPL-30 Labeling

Label is not available on this site.

03/21/1994 SUPPL-27 Efficacy-New Dosing Regimen

Label is not available on this site.

04/01/1993 SUPPL-24 Efficacy-New Patient Population

Label is not available on this site.

03/14/1991 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1990 SUPPL-20 Efficacy-New Indication

Label is not available on this site.

03/16/1989 SUPPL-18 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017970_S018_Nolvadex.pdf
11/25/1987 SUPPL-17 Labeling

Label is not available on this site.

12/03/1986 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

04/05/1984 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1984 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1985 SUPPL-9 Labeling

Label is not available on this site.

12/10/1985 SUPPL-8 Labeling

Label is not available on this site.

03/29/1982 SUPPL-6 Labeling

Label is not available on this site.

12/18/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1979 SUPPL-3 Labeling

Label is not available on this site.

07/24/1979 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/25/1978 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2006 SUPPL-54 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017970s054lbl.pdf
03/17/2005 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf
12/14/2004 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf
06/10/2003 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17970slr048_nolvadex_lbl.pdf
01/30/2003 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_prntlbl.pdf
08/30/2002 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21109lbl,17970s50lbl.pdf
05/16/2002 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf
05/16/2002 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf
05/16/2002 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf
06/29/2000 SUPPL-46 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/17970S46LBL.PDF
10/29/1998 SUPPL-40 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf
10/29/1998 SUPPL-39 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf

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