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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021920
Company: BIONPHARMA

Other Important Information from FDA

Products on NDA 021920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021920

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021920s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021920s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021920s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2021	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021920Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021920Orig1s036ltr.pdf
12/12/2020	SUPPL-33	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021920Orig1s033ltr.pdf
04/30/2020	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021920Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021920Orig1s028ltr.pdf
02/27/2020	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021920Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021920Orig1s027ltr.pdf
12/09/2019	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s026ltr.pdf
10/26/2019	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s025ltr.pdf
02/20/2019	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s023ltr.pdf
11/29/2018	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021920Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021920Orig1s022ltr.pdf
03/16/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021920Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021920Orig1s019ltr.pdf
04/01/2013	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021920Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021920Orig1s018ltr.pdf
06/13/2012	SUPPL-17	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021920s017ltr.pdf
08/12/2010	SUPPL-13	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021920s013ltr.pdf
07/14/2009	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021920s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s011ltr.pdf
04/15/2009	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s010ltr.pdf

Labels for NDA 021920

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2021	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021920Orig1s036lbl.pdf
04/30/2020	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021920Orig1s028lbl.pdf
02/27/2020	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021920Orig1s027lbl.pdf
12/09/2019	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s026lbl.pdf
10/26/2019	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s025lbl.pdf
02/20/2019	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s023lbl.pdf
11/29/2018	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021920Orig1s022lbl.pdf
03/16/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021920Orig1s019lbl.pdf
04/01/2013	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021920Orig1s018lbl.pdf
07/14/2009	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021920s011lbl.pdf
02/17/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021920s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

NAPROXEN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; EQ 200MG BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	Yes	021920	BIONPHARMA
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	No	202807	CATALENT
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	No	214463	PATHEON SOFTGELS
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	No	208363	PURACAP PHARM LLC

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