← FDA DRUG APPROVALS

FDA NDA · NDA020615

DURACLON

clonidine hydrochloride

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
NDA020615
TYPE
NDA
ORIGINAL APPROVAL
1996-10-02
LATEST ACTION
2016-08-01
ROUTE
EPIDURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

DURACLON · ReferencePrescription
CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) · INJECTABLE · INJECTION
DURACLON · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2016-08-01Manufacturing (CMC) · Supplement 8 · standardAP
2013-03-12Manufacturing (CMC) · Supplement 5 · standardAP
2013-01-11Manufacturing (CMC) · Supplement 4 · standardAP
2010-07-28Labeling · Supplement 3 · standard — Label ↗AP
2009-04-24Labeling · Supplement 2 · standard — Label ↗AP
1999-04-27Manufacturing (CMC) · Supplement 1 · standardAP
1996-10-02Type 3 - New Dosage Form · Original · standard — Review ↗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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