Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022234
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
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-Patient Package Insert, Labeling-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
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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf
09/27/2017 SUPPL-8 Labeling-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 Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
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 Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
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 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 Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
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 201525 SANDOZ

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