Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202356
Company: PFIZER LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Discontinued None No No
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Discontinued None No No
DOCETAXEL DOCETAXEL 130MG/13ML (10MG/ML) INJECTABLE;INJECTION Discontinued None No No
DOCETAXEL DOCETAXEL 200MG/20ML (10MG/ML) INJECTABLE;INJECTION Discontinued None 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
03/13/2014 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/2014/202356s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202356Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202356Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202356Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2018 SUPPL-3 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
11/21/2017 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202356s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202356Orig1S002ltr.pdf
12/02/2014 SUPPL-1 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-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf
11/21/2017 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202356s002lbl.pdf
11/21/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202356s002lbl.pdf
03/13/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202356s000lbl.pdf

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