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FDA NDA · NDA203922

SODIUM NITRITE

Sponsor: HOPE PHARMS

APPLICATION
NDA203922
TYPE
NDA
ORIGINAL APPROVAL
2012-02-14
LATEST ACTION
2021-01-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SODIUM NITRITE · ReferencePrescription
SODIUM NITRITE 300MG/10ML (30MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-01-13Labeling · Supplement 3 · standard — Letter ↗AP
2017-10-19Labeling · Supplement 1 · standard — Letter ↗AP
2012-02-14Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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