Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020449
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAXOTERE | DOCETAXEL | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| TAXOTERE | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| TAXOTERE | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| TAXOTERE | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/14/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020449Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/18/2023 | SUPPL-86 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020449s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020449Orig1s086ltr.pdf | |
| 04/27/2022 | SUPPL-85 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020449s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020449Orig1s085ltr.pdf | |
| 05/15/2020 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020449s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020449Orig1s084ltr.pdf | |
| 12/17/2019 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020449Orig1s083ltr.pdf | |
| 06/06/2019 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449Orig1s080,020449Orig1s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020449Orig1s080,%20020449Orig1s082ltr.pdf | |
| 06/06/2019 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449Orig1s080,020449Orig1s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020449Orig1s080, 020449Orig1s082ltr.pdf | |
| 10/05/2018 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020449s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020449Orig1s079ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020449Orig1s079.pdf | |
| 12/11/2015 | SUPPL-75 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020449Orig1s075ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020449Orig1s075.pdf | |
| 05/17/2016 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/2014 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020449Orig1s073ltr.pdf | |
| 05/15/2014 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/2013 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s071ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/020449Orig1s071.pdf | |
| 08/15/2013 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s069ltr.pdf | |
| 11/21/2012 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/2011 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s065ltr.pdf | |
| 09/07/2011 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s064ltr.pdf | |
| 04/13/2012 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf | |
| 05/13/2010 | SUPPL-59 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s059ltr.pdf | |
| 08/02/2010 | SUPPL-54 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s054.pdf |
| 04/20/2010 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf | |
| 09/28/2007 | SUPPL-45 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020449s045ltr.pdf | |
| 04/20/2010 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf | |
| 06/03/2010 | SUPPL-43 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s043.pdf |
| 10/17/2006 | SUPPL-39 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449s039.pdf | |
| 06/07/2006 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s036LTR.pdf | |
| 03/22/2006 | SUPPL-35 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449S035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449Orig1s035.pdf | |
| 11/05/2005 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s034ltr.pdf |
| 08/11/2005 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020449s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s033ltr.pdf | |
| 01/06/2005 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20449s031ltr.pdf |
| 08/18/2004 | SUPPL-29 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s029_Taxotere.cfm | |
| 05/19/2004 | SUPPL-28 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449se1-028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s028_Taxotere.cfm | |
| 01/30/2003 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf | |
| 07/30/2002 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf | |
| 11/27/2002 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20449se1-018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-449s018_Taxotere.cfm | |
| 07/09/2002 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/020449Orig1s017.pdf | |
| 04/24/2003 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020449s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr016ltr.pdf | |
| 11/30/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20449S11LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20449S11LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20449-S011_Taxotere.cfm | |
| 03/31/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf |
| 06/22/1998 | SUPPL-5 | Efficacy-Accelerated Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf |
| 01/06/1998 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20449S004_Taxotere.pdf |
| 05/15/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/28/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/18/2023 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020449s086lbl.pdf | |
| 01/18/2023 | SUPPL-86 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020449s086lbl.pdf | |
| 04/27/2022 | SUPPL-85 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020449s085lbl.pdf | |
| 04/27/2022 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020449s085lbl.pdf | |
| 05/15/2020 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020449s084lbl.pdf | |
| 12/17/2019 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s083lbl.pdf | |
| 06/06/2019 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449Orig1s080,020449Orig1s082lbl.pdf | |
| 06/06/2019 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449Orig1s080,020449Orig1s082lbl.pdf | |
| 10/05/2018 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020449s079lbl.pdf | |
| 12/11/2015 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf | |
| 12/11/2015 | SUPPL-75 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf | |
| 11/14/2014 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf | |
| 12/13/2013 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf | |
| 06/26/2013 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf | |
| 04/13/2012 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf | |
| 12/15/2011 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s065lbl.pdf | |
| 09/07/2011 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf | |
| 05/13/2010 | SUPPL-59 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf | |
| 04/20/2010 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf | |
| 04/20/2010 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf | |
| 09/28/2007 | SUPPL-45 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf | |
| 10/17/2006 | SUPPL-39 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf | |
| 06/07/2006 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036lbl.pdf | |
| 03/22/2006 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf | |
| 08/11/2005 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020449s033lbl.pdf | |
| 08/18/2004 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s029lbl.pdf | |
| 05/19/2004 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf | |
| 04/24/2003 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020449s016lbl.pdf | |
| 01/30/2003 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf | |
| 11/27/2002 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf | |
| 07/30/2002 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf | |
| 07/09/2002 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf | |
| 12/23/1999 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20449S11LBL.PDF |
TAXOTERE
INJECTABLE;INJECTION; 20MG/ML (20MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 201195 | ACCORD HLTHCARE |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216677 | ACIC PHARMS |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203551 | ACTAVIS |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209640 | AMNEAL |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204193 | DR REDDYS |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207252 | HENGRUI PHARMA |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204490 | HIKMA |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 205934 | SHILPA |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210327 | SHILPA |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 022534 | SUN PHARM |
| TAXOTERE | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |
INJECTABLE;INJECTION; 80MG/4ML (20MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 201195 | ACCORD HLTHCARE |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216677 | ACIC PHARMS |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203551 | ACTAVIS |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209640 | AMNEAL |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204193 | DR REDDYS |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207252 | HENGRUI PHARMA |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204490 | HIKMA |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 205934 | SHILPA |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210327 | SHILPA |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 022534 | SUN PHARM |
| TAXOTERE | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |
INJECTABLE;INJECTION; 160MG/8ML (20MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 201195 | ACCORD HLTHCARE |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203551 | ACTAVIS |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209640 | AMNEAL |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207252 | HENGRUI PHARMA |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208137 | MYLAN LABS LTD |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 205934 | SHILPA |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210327 | SHILPA |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 022534 | SUN PHARM |
| TAXOTERE | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020449 | SANOFI AVENTIS US |