FDA NDA · NDA201444

NITHIODOTE

sodium nitrite and sodium thiosulfate

Sponsor: HOPE PHARMS

APPLICATION

NDA201444

TYPE

NDA

ORIGINAL APPROVAL

2011-01-14

LATEST ACTION

2021-01-13

ROUTE

INTRAVENOUS, INTRAVENOUS

DOSAGE FORM

SOLUTION, SOLUTION

MARKETING STATUS

Prescription

Products

NITHIODOTE · ReferencePrescription

SODIUM NITRITE 300MG/10ML(30MG/ML),N/A, SODIUM THIOSULFATE N/A,12.5GM/50ML(250MG/ML) · SOLUTION, SOLUTION · INTRAVENOUS, INTRAVENOUS

2021-01-13Labeling · Supplement 26 · standard — Letter ↗AP

2017-10-19Labeling · Supplement 19 · standard — Letter ↗AP

2016-06-14Manufacturing (CMC) · Supplement 17 · priorityAP

2016-04-22Manufacturing (CMC) · Supplement 18 · priorityAP

2015-02-03Manufacturing (CMC) · Supplement 16 · priorityAP

2015-01-26Manufacturing (CMC) · Supplement 15 · priorityAP

2014-11-24Manufacturing (CMC) · Supplement 13 · priorityAP

2014-06-03Manufacturing (CMC) · Supplement 12 · priorityAP

2013-11-14Manufacturing (CMC) · Supplement 11 · priorityAP

2013-04-08Manufacturing (CMC) · Supplement 10 · priorityAP

2013-03-28Manufacturing (CMC) · Supplement 9 · priorityAP

2011-01-14Type 5 - New Formulation or New Manufacturer · Original · priority — 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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