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FDA NDA · NDA021780

NITROMIST

Sponsor: EVUS

APPLICATION
NDA021780
TYPE
NDA
ORIGINAL APPROVAL
2006-11-02
LATEST ACTION
2022-06-24
ROUTE
SUBLINGUAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

NITROMIST · ReferencePrescription
NITROGLYCERIN 0.4MG/SPRAY · AEROSOL, METERED · SUBLINGUAL

Approval history

2022-06-24Labeling · Supplement 8 · standard — Letter ↗AP
2016-06-10Labeling · Supplement 7 · standard — Letter ↗AP
2011-03-08Labeling · Supplement 3 · unknown — Label ↗AP
2006-11-02Type 3 - New Dosage Form · 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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