APPLICATION
ANDA203700
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-25
LATEST ACTION
2013-02-25
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMMONIA N 13Prescription
AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) · INJECTABLE · INTRAVENOUS
Approval history
2013-02-25UNKNOWN · OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.