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FDA ANDA · ANDA204506

AMMONIA N 13

nh3n13

Sponsor: WA UNIV SCH MED

APPLICATION
ANDA204506
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-07
LATEST ACTION
2026-02-13
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMMONIA N 13Prescription
AMMONIA N-13 37.5mCi-800mCi/10ML (3.75-80mCi/ML) · INJECTABLE · INTRAVENOUS
AMMONIA N 13Prescription
AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-02-13Manufacturing (CMC) · Supplement 4 · unknownAP
2014-02-07UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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