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FDA NDA · NDA204623

PENNSAID

Sponsor: HORIZON

APPLICATION
NDA204623
TYPE
NDA
ORIGINAL APPROVAL
2014-01-16
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PENNSAID · ReferenceDiscontinued
DICLOFENAC SODIUM 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2024-11-21Labeling · Supplement 13 · standard — Letter ↗AP
2022-01-27Labeling · Supplement 9 · standard — Label ↗AP
2021-06-07Labeling · Supplement 10 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 11 · standard — Letter ↗AP
2016-10-31Manufacturing (CMC) · Supplement 7 · standardAP
2016-08-11Labeling · Supplement 6 · standard — Label ↗AP
2016-05-09Labeling · Supplement 5 · standard — Label ↗AP
2015-05-06Manufacturing (CMC) · Supplement 4 · standardAP
2014-11-05Labeling · Supplement 3 · standard — Label ↗AP
2014-07-21Manufacturing (CMC) · Supplement 1 · standardAP
2014-07-10Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2014-01-16Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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