APPLICATION
ANDA204352
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-01
LATEST ACTION
2015-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMMONIA N 13Prescription
AMMONIA N-13 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML) · INJECTABLE · INTRAVENOUS
Approval history
2015-05-01UNKNOWN · 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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