← FDA DRUG APPROVALS

FDA NDA · NDA021566

PREVACID IV

Sponsor: TAKEDA PHARMS NA

APPLICATION
NDA021566
TYPE
NDA
ORIGINAL APPROVAL
2004-05-27
LATEST ACTION
2009-07-31
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PREVACID IV · ReferenceDiscontinued
LANSOPRAZOLE 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2009-07-31Supplement · Supplement 5 · standard — Letter ↗AP
2007-05-16Labeling · Supplement 4 · standard — Letter ↗AP
2006-12-29Labeling · Supplement 2 · standard — Letter ↗AP
2005-04-05Labeling · Supplement 1 · standard — Label ↗AP
2004-05-27Type 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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