Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017970
Company: ASTRAZENECA
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| NOLVADEX | TAMOXIFEN CITRATE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| NOLVADEX | TAMOXIFEN CITRATE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17970s052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/017970Orig1s052.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. |
||
| 03/13/2009 | 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. |
||
| 03/13/2009 | 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. |
||
| 03/13/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/21/1994 | SUPPL-27 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-24 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-22 | Labeling |
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. |
||
| 03/13/2009 | SUPPL-19 | Labeling |
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. |
||
| 03/13/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/03/1986 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-12 | Labeling |
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. |
||
| 03/13/2009 | SUPPL-7 | Efficacy |
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 |
|---|---|---|---|---|---|
| 03/13/2009 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf | |
| 03/13/2009 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf | |
| 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 | |
| 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 |