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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210833
Company: OTTER PHARMS

Medication Guide

Products on NDA 210833

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYMPAZAN	CLOBAZAM	5MG	FILM;ORAL	Prescription	None	Yes	No
SYMPAZAN	CLOBAZAM	10MG	FILM;ORAL	Prescription	None	Yes	No
SYMPAZAN	CLOBAZAM	20MG	FILM;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210833s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210833Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210833Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2024	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210833s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210833Orig1s006ltr.pdf
01/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210833s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210833Orig1s004ltr.pdf
02/05/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210833Orig1s003ltr.pdf
03/16/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210833Orig1s002ltr.pdf
12/09/2020	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210833Orig1s001ltr.pdf

Labels for NDA 210833

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210833s006lbl.pdf
01/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210833s004lbl.pdf
03/16/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s002lbl.pdf
02/05/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s003lbl.pdf
11/01/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210833s000lbl.pdf

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