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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209899
Company: BRISTOL

Medication Guide

Products on NDA 209899

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEPOSIA	OZANIMOD HYDROCHLORIDE	EQ 0.23MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
ZEPOSIA	OZANIMOD HYDROCHLORIDE	EQ 0.46MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
ZEPOSIA	OZANIMOD HYDROCHLORIDE	EQ 0.92MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209899

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209899s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209899Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209899Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209899Orig01s013,s014ltr.pdf
06/05/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209899Orig01s013,s014ltr.pdf
08/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209899Orig1s011, s012ltr.pdf
08/30/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209899Orig1s011, s012ltr.pdf
08/10/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.pdf
08/10/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.pdf
09/29/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209899s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209899Orig1s005ltr.pdf
12/15/2021	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209899Orig1s003ltr.pdf
05/27/2021	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209899Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/209899Orig1s001.pdf

Labels for NDA 209899

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s011s012lbl.pdf
08/30/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s011s012lbl.pdf
06/05/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s013s014lbl.pdf
06/05/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209899s013s014lbl.pdf
08/10/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.pdf
08/10/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.pdf
09/29/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209899s005lbl.pdf
12/15/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf
12/15/2021	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf
05/27/2021	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s001lbl.pdf
03/25/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209899s000lbl.pdf

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