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FDA NDA · NDA204592

ZORVOLEX

Sponsor: ZYLA

APPLICATION
NDA204592
TYPE
NDA
ORIGINAL APPROVAL
2013-10-18
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZORVOLEX · ReferenceDiscontinued
DICLOFENAC 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZORVOLEX · ReferenceDiscontinued
DICLOFENAC 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 14 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 13 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 7 · standard — Label ↗AP
2016-05-09Labeling · Supplement 8 · standard — Letter ↗AP
2015-01-29Manufacturing (CMC) · Supplement 6 · standardAP
2014-08-22Labeling · Supplement 4 · standard — Review ↗AP
2014-08-22Efficacy · Supplement 2 · standard — Review ↗AP
2014-08-11Manufacturing (CMC) · Supplement 3 · standardAP
2014-04-14Manufacturing (CMC) · Supplement 1 · standardAP
2013-10-18Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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