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FDA NDA · NDA021012

NEO TECT KIT

Sponsor: CIS BIO INTL SA

APPLICATION
NDA021012
TYPE
NDA
ORIGINAL APPROVAL
1999-08-03
LATEST ACTION
2004-10-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NEO TECT KITDiscontinued
TECHNETIUM TC-99M DEPREOTIDE N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2004-10-01Manufacturing (CMC) · Supplement 7 · priority — Letter ↗AP
2002-01-30Manufacturing (CMC) · Supplement 3 · priorityAP
2001-04-26Manufacturing (CMC) · Supplement 1 · priorityAP
2001-04-11Manufacturing (CMC) · Supplement 2 · priorityAP
1999-08-03Type 1 - New Molecular Entity · Original · priority — 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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