FDA NDA · NDA019928

CARDIOTEC

Sponsor: BRACCO

APPLICATION

NDA019928

TYPE

NDA

ORIGINAL APPROVAL

1990-12-19

LATEST ACTION

2003-04-17

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

CARDIOTECDiscontinued

TECHNETIUM TC-99M TEBOROXIME KIT N/A · INJECTABLE · INJECTION

2003-04-17Labeling · Supplement 2 · standard — Letter ↗AP

2002-01-09Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP

1990-12-19Type 1 - New Molecular Entity · Original · priorityAP

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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