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Drugs@FDA: FDA-Approved Drugs

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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
08/07/2024	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022122Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022122Orig1s026ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	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-Package Insert, Labeling-Container/Carton Labels		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
08/07/2024	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022122Orig1s026lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf
02/21/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.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
05/09/2016	SUPPL-10	Labeling-Medication Guide	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	209903	CIPLA
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

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