Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022234
Company: HOSPIRA INC
Company: HOSPIRA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | No |
DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | No |
DOCETAXEL | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | 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 |
---|---|---|---|---|---|---|---|
03/08/2011 | 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/2011/022234s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022234s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022234s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/15/2023 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022234s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022234Orig1s022ltr.pdf | |
11/24/2020 | SUPPL-18 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022234s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022234Orig1s018ltr.pdf | |
10/11/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf | |
10/11/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf | |
10/11/2019 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf | |
09/24/2018 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s011,202356Orig1s003ltr.pdf | |
08/02/2018 | SUPPL-10 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234Orig1s010Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s010Ltr.pdf | ||
09/27/2017 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022234Orig1s008ltr.pdf | |
01/25/2017 | SUPPL-5 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s005lbl.pdf | |
06/24/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/10/2014 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022234Orig1s003ltr.pdf | |
01/23/2014 | SUPPL-2 | 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 |
---|---|---|---|---|---|
05/15/2023 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022234s022lbl.pdf | |
11/24/2020 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022234s018lbl.pdf | |
10/11/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf | |
10/11/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf | |
10/11/2019 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf | |
10/11/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf | |
09/24/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf | |
08/02/2018 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234Orig1s010Lbl.pdf | |
09/27/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf | |
09/27/2017 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf | |
01/25/2017 | SUPPL-5 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s005lbl.pdf |
07/10/2014 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf | |
03/08/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022234s000lbl.pdf |
DOCETAXEL
INJECTABLE;INJECTION; 20MG/2ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215744 | ALEMBIC |
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214575 | EUGIA PHARMA |
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213510 | GLAND PHARMA LTD |
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022234 | HOSPIRA INC |
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209634 | MEITHEAL |
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210072 | MYLAN LABS LTD |
DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201525 | SANDOZ |
INJECTABLE;INJECTION; 80MG/8ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215744 | ALEMBIC |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214575 | EUGIA PHARMA |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213510 | GLAND PHARMA LTD |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022234 | HOSPIRA INC |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209634 | MEITHEAL |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210848 | MYLAN LABS LTD |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207563 | NOVAST LABS |
DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201525 | SANDOZ |
INJECTABLE;INJECTION; 160MG/16ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215744 | ALEMBIC |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214575 | EUGIA PHARMA |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213510 | GLAND PHARMA LTD |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022234 | HOSPIRA INC |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209634 | MEITHEAL |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208859 | MYLAN LABS LTD |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207563 | NOVAST LABS |
DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201525 | SANDOZ |