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Drugs@FDA: FDA-Approved Drugs

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

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

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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