Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201195
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 20MG/0.5ML (40MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DOCETAXEL | DOCETAXEL | 80MG/2ML (40MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
DOCETAXEL | 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 |
---|---|---|---|---|---|---|---|
06/08/2011 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201195s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201195s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/20/2023 | SUPPL-19 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201195Orig1s019ltr.pdf | |
07/20/2020 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201195s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201195Orig1s015ltr.pdf | |
06/21/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201195s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201195Orig1s013ltr.pdf | |
07/26/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201195s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201195Orig1s009ltr.pdf | |
10/21/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/27/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/2014 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201195Orig1s006ltr.pdf | |
11/06/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/2013 | SUPPL-4 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/20/2023 | SUPPL-19 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf | |
09/20/2023 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf | |
09/20/2023 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf | |
07/20/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201195s015lbl.pdf | |
06/21/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201195s013lbl.pdf | |
07/26/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201195s009lbl.pdf | |
07/03/2014 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf | |
07/03/2014 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf | |
04/05/2013 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf |
06/08/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201195s000lbl.pdf |
DOCETAXEL
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 | 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 | 216677 | HERITAGE |
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 | 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 | 216677 | HERITAGE |
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 |