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FDA NDA · NDA021749

PENTETATE CALCIUM TRISODIUM

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APPLICATION
NDA021749
TYPE
NDA
ORIGINAL APPROVAL
2004-08-11
LATEST ACTION
2016-07-08
ROUTE
INHALATION, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PENTETATE CALCIUM TRISODIUM · ReferenceDiscontinued
PENTETATE CALCIUM TRISODIUM EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION, INTRAVENOUS

Approval history

2016-07-08Manufacturing (CMC) · Supplement 10 · priorityAP
2015-02-16Manufacturing (CMC) · Supplement 9 · priorityAP
2013-03-21Labeling · Supplement 8 · standard — Letter ↗AP
2005-08-04Labeling · Supplement 2 · standard — Letter ↗AP
2004-08-11Type 1 - New Molecular Entity · Original · priority — Label ↗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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