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FDA NDA · NDA022122

VOLTAREN ARTHRITIS PAIN

diclofenac sodium

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA022122
TYPE
NDA
ORIGINAL APPROVAL
2007-10-17
LATEST ACTION
2024-08-07
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter

Products

VOLTAREN ARTHRITIS PAIN · ReferenceOver-the-counter
DICLOFENAC SODIUM 1% · GEL · TOPICAL

Approval history

2024-08-07Labeling · Supplement 26 · standard — Letter ↗AP
2023-11-29Labeling · Supplement 25 · standard — Letter ↗AP
2023-02-21Labeling · Supplement 23 · standard — Letter ↗AP
2022-11-23Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2021-11-03Labeling · Supplement 18 · standard — Letter ↗AP
2021-07-19Manufacturing (CMC) · Supplement 17 — Letter ↗AP
2020-12-12Labeling · Supplement 16 · standard — Letter ↗AP
2020-02-14Efficacy · Supplement 14 · standard — Label ↗AP
2018-02-21Labeling · Supplement 11 · standard — Label ↗AP
2016-05-09Labeling · Supplement 10 · standard — Label ↗AP
2015-05-11Manufacturing (CMC) · Supplement 9 · standardAP
2014-11-25Labeling · Supplement 7 · standard — Label ↗AP
2014-09-29Manufacturing (CMC) · Supplement 8AP
2010-12-07Manufacturing (CMC) · Supplement 3AP
2009-09-23Labeling · Supplement 6 · 901 required — Label ↗AP
2009-09-04Manufacturing (CMC) · Supplement 4AP
2007-10-17Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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