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FDA NDA · NDA019922

CORLOPAM

Sponsor: HOSPIRA

APPLICATION
NDA019922
TYPE
NDA
ORIGINAL APPROVAL
1997-09-23
LATEST ACTION
2020-09-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CORLOPAM · ReferenceDiscontinued
FENOLDOPAM MESYLATE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-09-02Labeling · Supplement 19 · standard — Letter ↗AP
2015-12-17Labeling · Supplement 16 · standard — Letter ↗AP
2006-03-22Manufacturing (CMC) · Supplement 10AP
2004-04-01Efficacy · Supplement 5 · priority — Letter ↗AP
2000-07-06Manufacturing (CMC) · Supplement 2 · standardAP
1998-01-13Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-23Type 1 - New Molecular Entity · 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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