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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022119

AMMONIA N 13 (AMMONIA N-13)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Marketing Status: Prescription
Active Ingredient: AMMONIA N-13
Proprietary Name: AMMONIA N 13
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022119
Product Number: 001
Approval Date: Aug 23, 2007
Applicant Holder Full Name: FEINSTEIN INSTITUTE MEDICAL RESEARCH
Marketing Status:  Prescription
Patent and Exclusivity Information
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