APPLICATION
NDA017869
TYPE
NDA
ORIGINAL APPROVAL
1976-11-10
LATEST ACTION
1996-02-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FUNDUSCEIN-25 · ReferenceDiscontinued
FLUORESCEIN SODIUM 25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1996-02-14Labeling · Supplement 5 · standardAP
1987-06-25Labeling · Supplement 3 · standardAP
1986-08-25Manufacturing (CMC) · Supplement 4 · standardAP
1982-09-15Manufacturing (CMC) · Supplement 2 · standardAP
1980-05-27Manufacturing (CMC) · Supplement 1 · standardAP
1976-11-10Type 1 - New Molecular Entity · Original · standardAP
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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