← FDA DRUG APPROVALS

FDA NDA · NDA209387

NIPRIDE RTU

sodium nitroprusside

Sponsor: EXELA PHARMA

APPLICATION
NDA209387
TYPE
NDA
ORIGINAL APPROVAL
2017-03-08
LATEST ACTION
2018-07-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% · ReferencePrescription
SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) · SOLUTION · INTRAVENOUS
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% · ReferencePrescription
SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) · SOLUTION · INTRAVENOUS
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2018-07-13Manufacturing (CMC) · Supplement 4 — Label ↗AP
2018-05-23Labeling · Supplement 3 · standard — Letter ↗AP
2017-03-08Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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