An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022122
Company: HALEON US HOLDINGS

Medication Guide

Summary Review

Products on NDA 022122

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/02212s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/Voltaren_022122.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022122_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2023	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022122Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022122Orig1s025ltr.pdf
02/21/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022122Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022122Orig1s023ltr.pdf
11/23/2022	SUPPL-22	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022122Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022122Orig1s022ltr.pdf
11/03/2021	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022122Orig1s018Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022122Orig1s018ltr.pdf
07/19/2021	SUPPL-17	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022122Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022122Orig1s017ltr.pdf
12/12/2020	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022122Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022122Orig1s016ltr.pdf
02/14/2020	SUPPL-14	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022122Origs014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022122Orig1s014ltr.pdf
02/21/2018	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022122Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/022122Orig1s011.pdf
05/09/2016	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022122Orig1s010ltr.pdf
05/11/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/29/2014	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/25/2014	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022122Orig1s007ltr.pdf
09/23/2009	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022122s006ltr.pdf
09/04/2009	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/07/2010	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 022122

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2023	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022122Orig1s025lbl.pdf
02/21/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022122Orig1s023lbl.pdf
11/23/2022	SUPPL-22	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022122Orig1s022lbl.pdf
11/03/2021	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022122Orig1s018Lbl.pdf
07/19/2021	SUPPL-17	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022122Orig1s017lbl.pdf
12/12/2020	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022122Orig1s016lbl.pdf
02/14/2020	SUPPL-14	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022122Origs014lbl.pdf
02/21/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf
02/21/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf
05/09/2016	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
05/09/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
05/09/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
11/25/2014	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf
09/23/2009	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf
10/17/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf

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

VOLTAREN ARTHRITIS PAIN

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

GEL;TOPICAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	208077	AMNEAL PHARMS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	204306	AUROLIFE PHARMA LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	210986	ENCUBE
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	211253	PERRIGO PHARMA INTL
VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	Yes	022122	HALEON US HOLDINGS

Top