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FDA NDA · NDA020438

VESANOID

Sponsor: CHEPLAPHARM

APPLICATION
NDA020438
TYPE
NDA
ORIGINAL APPROVAL
1995-11-22
LATEST ACTION
2024-10-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

VESANOID · ReferenceDiscontinued
TRETINOIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2024-10-04Labeling · Supplement 9 · standard — Letter ↗AP
2023-02-21Labeling · Supplement 7 · standard — Label ↗AP
2023-02-21Efficacy · Supplement 8 · priority — Label ↗AP
2008-07-01Labeling · Supplement 6 · standard — Label ↗AP
2004-10-05Labeling · Supplement 4 · standard — Letter ↗AP
2000-02-14Labeling · Supplement 1 · standard — Review ↗AP
1995-11-22Type 3 - New Dosage Form · Original · priorityAP
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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