APPLICATION
ANDA203543
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2023-05-12
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMMONIA N 13Prescription
AMMONIA N-13 3.75mCi-260mCi/ML · INJECTABLE · INTRAVENOUS
Approval history
2023-05-12Manufacturing (CMC) · Supplement 2 · unknownAP
2012-12-14UNKNOWN · 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.
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