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FDA NDA · NDA018581

SODIUM NITROPRUSSIDE

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA018581
TYPE
NDA
ORIGINAL APPROVAL
1982-07-28
LATEST ACTION
1998-01-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

SODIUM NITROPRUSSIDE · ReferenceDiscontinued
SODIUM NITROPRUSSIDE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

1998-01-16Manufacturing (CMC) · Supplement 20AP
1994-08-18Manufacturing (CMC) · Supplement 17AP
1992-05-14Manufacturing (CMC) · Supplement 13AP
1992-04-21Labeling · Supplement 16AP
1991-01-22Labeling · Supplement 15AP
1988-09-12Labeling · Supplement 10AP
1988-09-12Labeling · Supplement 11AP
1987-12-10Manufacturing (CMC) · Supplement 7AP
1987-04-21Manufacturing (CMC) · Supplement 6AP
1986-11-05Manufacturing (CMC) · Supplement 5AP
1982-07-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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