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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210656
Company: PFIZER

Medication Guide

Products on NDA 210656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAURISMO	GLASDEGIB MALEATE	EQ 25MG BASE	TABLET;ORAL	Prescription	None	Yes	No
DAURISMO	GLASDEGIB MALEATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210656Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210656Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-5	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210656s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210656Orig1s005ltr.pdf
03/19/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210656Orig1s002,s004ltr.pdf
03/19/2020	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210656Orig1s002,s004ltr.pdf

Labels for NDA 210656

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210656s005lbl.pdf
03/27/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210656s005lbl.pdf
03/19/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf
03/19/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf
03/19/2020	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf
11/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf

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