← FDA DRUG APPROVALS

FDA NDA · NDA022499

CLONIDINE

Sponsor: TRIS PHARMA INC

APPLICATION
NDA022499
TYPE
NDA
ORIGINAL APPROVAL
2009-12-03
LATEST ACTION
2010-09-23
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

CLONIDINEDiscontinued
CLONIDINE EQ 0.09MG BASE/ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2010-09-23Labeling · Supplement 1 · unknown — Label ↗AP
2009-12-03Type 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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