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FDA NDA · NDA021697

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

Sponsor: APOTEX

APPLICATION
NDA021697
TYPE
NDA
ORIGINAL APPROVAL
2005-12-29
LATEST ACTION
2016-10-14
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER · ReferencePrescription
CONIVAPTAN HYDROCHLORIDE 20MG/100ML (0.2MG/ML) · INJECTABLE · INTRAVENOUS
VAPRISOLDiscontinued
CONIVAPTAN HYDROCHLORIDE 20MG/4ML (5MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2016-10-14Labeling · Supplement 5 · standard — Letter ↗AP
2012-02-01Labeling · Supplement 3 · unknown — Letter ↗AP
2010-05-27Labeling · Supplement 2 · standard — Letter ↗AP
2008-10-08Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2005-12-29Type 1 - New Molecular Entity · Original · standard — Label ↗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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