APPLICATION
ANDA210524
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2020-01-31
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMMONIA N 13Prescription
AMMONIA N-13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) · INJECTABLE · INTRAVENOUS
Approval history
2020-01-31Manufacturing (CMC) · Supplement 1 · unknownAP
2018-12-21UNKNOWN · Original · standardAP
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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