Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022534
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOCEFREZ | DOCETAXEL | 20MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DOCEFREZ | DOCETAXEL | 80MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/03/2011 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534_docefrez_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2023 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022534s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022534Orig1s017ltr.pdf | |
| 12/09/2022 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022534s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022534Orig1s016ltr.pdf | |
| 02/01/2021 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022534s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022534Orig1s012ltr.pdf | |
| 02/25/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022534s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022534Orig1s011ltr.pdf | |
| 01/08/2019 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022534s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022534Orig1s007ltr.pdf | |
| 05/05/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2014 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022534Orig1s004ltr.pdf | |
| 06/21/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2012 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022534Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/22/2023 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022534s017lbl.pdf | |
| 12/09/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022534s016lbl.pdf | |
| 02/01/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022534s012lbl.pdf | |
| 02/01/2021 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022534s012lbl.pdf | |
| 02/25/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022534s011lbl.pdf | |
| 01/08/2019 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022534s007lbl.pdf | |
| 10/30/2014 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf | |
| 07/13/2012 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf | |
| 05/03/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf |
DOCEFREZ
There are no Therapeutic Equivalents.
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 | 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 |