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FDA NDA · NDA022411

OLEPTRO

Sponsor: ANGELINI PHARMA

APPLICATION
NDA022411
TYPE
NDA
ORIGINAL APPROVAL
2010-02-02
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

OLEPTRO · ReferenceDiscontinued
TRAZODONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OLEPTRO · ReferenceDiscontinued
TRAZODONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2014-07-17Labeling · Supplement 8 · 901 required — Label ↗AP
2012-11-13Labeling · Supplement 7 · standard — Letter ↗AP
2011-05-11REMS · Supplement 6AP
2011-05-11REMS · Supplement 5AP
2011-05-05Labeling · Supplement 4 · standard — Letter ↗AP
2010-02-02Type 3 - New Dosage Form · Original · standard — Review ↗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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