APPLICATION
NDA018450
TYPE
NDA
ORIGINAL APPROVAL
1981-09-08
LATEST ACTION
1991-12-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NITROPRESS · ReferenceDiscontinued
SODIUM NITROPRUSSIDE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1991-12-31Efficacy · Supplement 1 · standardAP
1990-09-21Labeling · Supplement 9 · standardAP
1990-02-20Manufacturing (CMC) · Supplement 7 · standardAP
1986-09-25Manufacturing (CMC) · Supplement 5 · standardAP
1984-12-05Labeling · Supplement 3 · standardAP
1984-10-11Manufacturing (CMC) · Supplement 4 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 2 · standardAP
1981-09-08Type 5 - New Formulation or New Manufacturer · 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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