← FDA DRUG APPROVALS

FDA NDA · NDA022119

AMMONIA N 13

nh3n13

Sponsor: FEINSTEIN

APPLICATION
NDA022119
TYPE
NDA
ORIGINAL APPROVAL
2007-08-23
LATEST ACTION
2011-01-05
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMMONIA N 13 · ReferencePrescription
AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) · INJECTABLE · INTRAVENOUS

Approval history

2011-01-05Labeling · Supplement 1 · unknown — Label ↗AP
2007-08-23Type 1 - New Molecular Entity · Original · standard — Letter ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →