Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). NDA 20449, held by Sanofi Aventis US. Docetaxel.
As of Nov 13, 2026, NDA 20449 (Taxotere), held by Sanofi Aventis US, was first approved by FDA on May 14, 1996, with 51 approved supplements and 0 published complete response letters.
Docetaxel is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction Squamous …
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2010 | Supplement 59Efficacy (new indication or use) · Priority review | Approved | |
| Sep 28, 2007 | Supplement 45Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2006 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | |
| Mar 22, 2006 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Aug 18, 2004 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| May 19, 2004 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Nov 27, 2002 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 23, 1999 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 1998 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 1996 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Taxotere40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Docetaxel | DiscontinuedReference drug |
| Taxotere20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Docetaxel | DiscontinuedReference drug |
| Taxotere80MG/4ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Docetaxel | DiscontinuedReference drug |
| Taxotere160MG/8ML (20MG/ML) · injectable;injection | Docetaxel | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 2023 | Supplement 86Labeling · Standard review | Approved | |
| Apr 27, 2022 | Supplement 85Labeling · Standard review | Approved | |
| May 15, 2020 | Supplement 84Labeling · Standard review | Approved | |
| Dec 17, 2019 | Supplement 83Labeling · Standard review | Approved | |
| Jun 6, 2019 | Supplement 82Labeling · Standard review | Approved | |
| Jun 6, 2019 | Supplement 80Labeling · Standard review | Approved | |
| Oct 5, 2018 | Supplement 79Labeling · Standard review | Approved | |
| May 17, 2016 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Dec 11, 2015 | Supplement 75Labeling · Standard review | Approved | |
| Nov 14, 2014 | Supplement 73Labeling · Standard review | Approved | |
| May 15, 2014 | Supplement 72Manufacturing · Priority review | Approved | None posted |
| Dec 13, 2013 | Supplement 71Labeling · Standard review | Approved | |
| Aug 15, 2013 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Jun 26, 2013 | Supplement 69Labeling · Standard review | Approved | |
| Nov 21, 2012 | Supplement 68Manufacturing · Priority review | Approved | None posted |
| Apr 13, 2012 | Supplement 63Manufacturing | Approved | |
| Dec 15, 2011 | Supplement 65Labeling | Approved | |
| Sep 7, 2011 | Supplement 64Labeling · Standard review | Approved | |
| Aug 2, 2010 | Supplement 54Manufacturing | Approved | |
| Jun 3, 2010 | Supplement 43Labeling · Standard review | Approved | |
| May 13, 2010 | Supplement 59Efficacy (new indication or use) · Priority review | Approved | |
| Apr 20, 2010 | Supplement 53Labeling · Standard review | Approved | |
| Apr 20, 2010 | Supplement 44Labeling · Standard review | Approved | |
| Sep 28, 2007 | Supplement 45Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2006 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | |
| Jun 7, 2006 | Supplement 36Labeling · Standard review | Approved | |
| Mar 22, 2006 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Nov 5, 2005 | Supplement 34Labeling · Standard review | Approved | |
| Aug 11, 2005 | Supplement 33Labeling · Standard review | Approved | |
| Jan 6, 2005 | Supplement 31Labeling · Standard review | Approved | |
| Aug 18, 2004 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| May 19, 2004 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Apr 24, 2003 | Supplement 16Labeling · Standard review | Approved | |
| Jan 30, 2003 | Supplement 22Labeling · Standard review | Approved | |
| Nov 27, 2002 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2002 | Supplement 19Labeling · Standard review | Approved | |
| Jul 9, 2002 | Supplement 17Labeling · Standard review | Approved | |
| Nov 30, 2000 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Sep 28, 2000 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Sep 28, 2000 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Dec 23, 1999 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Dec 6, 1999 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1999 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| May 18, 1999 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Mar 31, 1999 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 23, 1999 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jun 22, 1998 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 1998 | Supplement 6Labeling · Standard review | Approved | |
| May 15, 1998 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jan 6, 1998 | Supplement 4Labeling · Standard review | Approved | |
| Apr 28, 1997 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| May 14, 1996 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
