APPLICATION
ANDA203779
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-19
LATEST ACTION
2020-06-24
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
2020-06-24Manufacturing (CMC) · Supplement 1 · unknownAP
2015-10-19UNKNOWN · 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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