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FDA NDA · NDA017045

RENOTEC

Sponsor: BRACCO

APPLICATION
NDA017045
TYPE
NDA
ORIGINAL APPROVAL
1974-07-08
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2009-03-13Labeling · Supplement 10AP
1982-03-26Labeling · Supplement 9AP
1980-01-22Labeling · Supplement 8AP
1978-02-16Labeling · Supplement 7AP
1976-11-01Labeling · Supplement 5AP
1976-09-30Manufacturing (CMC) · Supplement 4 · standardAP
1975-12-10Labeling · Supplement 3AP
1974-07-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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