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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205266
Company: SUN PHARM

Medication Guide

Products on NDA 205266

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ODOMZO	SONIDEGIB PHOSPHATE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205266Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205266Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205266s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205266Orig1s009ltr.pdf
05/13/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205266s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205266Orig1s006ltr.pdf
09/18/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205266s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205266Orig1s004ltr.pdf
02/17/2016	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s003lbl.pdf
05/12/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205266Orig1s002ltr.pdf

Labels for NDA 205266

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205266s009lbl.pdf
05/13/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205266s006lbl.pdf
09/18/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205266s004lbl.pdf
05/12/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf
02/17/2016	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s003lbl.pdf
07/24/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266Orig1s000lbl.pdf

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