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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202356
Company: PFIZER LABS

Summary Review

Products on NDA 202356

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202356

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.

Labels for NDA 202356

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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