Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020353
Company: TWI PHARMS

• Medication Guide

Products on NDA 20353

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPRELAN	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
NAPRELAN	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
NAPRELAN	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020353

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020353s041lbl.pdf
04/28/2021	SUPPL-38	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf
04/28/2021	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf
07/22/2019	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf
07/22/2019	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf
07/22/2019	SUPPL-36	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf
09/06/2017	SUPPL-34	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020353s034lbl.pdf
05/09/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
05/09/2016	SUPPL-31	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
05/09/2016	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
11/08/2011	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf
07/08/2009	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf
07/08/2009	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf
01/18/2006	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf