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

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

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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