Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211288
Company: PFIZER

Products on NDA 211288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIZIMPRO	DACOMITINIB	15MG	TABLET;ORAL	Prescription	None	Yes	No
VIZIMPRO	DACOMITINIB	30MG	TABLET;ORAL	Prescription	None	Yes	No
VIZIMPRO	DACOMITINIB	45MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211288Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211288Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211288s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211288Orig1s003ltr.pdf

Labels for NDA 211288

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211288s003lbl.pdf
09/27/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf